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Trial record 6 of 8 for:    artemisinin | cancer

A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART)

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ClinicalTrials.gov Identifier: NCT02633098
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE December 17, 2015
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE April 26, 2017
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
Recurrence free survival at 2 years [ Time Frame: 2 years following study randomisation. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Recurrence free survival at 5 years [ Time Frame: 5 years from study randomisation ]
  • Overall survival at 2 and 5 years [ Time Frame: 2 and 5 years from study randomisation ]
  • Colon cancer specific death at 2 and 5 years [ Time Frame: 2 and 5 years from study randomisation ]
  • Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 7 following start of study intervention (artesunate/matching placebo) ]
  • Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 14 following start of study intervention (artesunate/matching placebo) ]
  • Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 42 following start of study intervention (artesunate/matching placebo) ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 7 following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 14 following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 42 following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 6 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 12 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 18 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 24 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 30 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 36 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 42 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 48 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 54 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 60 months following study intervention ]
  • Pathological assessment of tumour regression (involvement of lymph nodes; serosa; resection margin) [ Time Frame: Post surgical pathology review (following Day 14 of study intervention) ]
  • Patient quality of life [ Time Frame: Assessment at Day 1 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment at Day 7 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment at Day 14 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment at Day 42 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Surgical complications [ Time Frame: From time of surgery up to 3 months post surgery ]
    Number of patients with surgery related adverse events as assessed by CTCAE v4.0
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 1 of study intervention ]
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 7 of study intervention ]
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 14 of study intervention ]
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 42 of study intervention ]
  • Immunohistochemical analyses of paraffin-embedded tumour sections to assess Kirsten rat sarcoma viral oncogene homolog (Kras) mutation status [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients with Kras mutant tumours
  • Immunohistochemical analyses of paraffin-embedded tumour sections to assess Mismatch Repair (MMR) status [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients with Mismatch Repair (MMR) mutant tumours
  • Immunohistochemical analyses of paraffin-embedded tumour for v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation status [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients with BRAF mutant tumours
  • Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor (PDGF) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show PDGF upregulation/downregulation following treatment intervention
  • Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor receptor (PDGFR) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show PDGFR upregulation/downregulation following study intervention
  • Immunohistochemical analyses of paraffin-embedded tumour for Vascular endothelial Growth Factor (VEGF) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show VEGF upregulation/downregulation following study intervention
  • Immunohistochemical analyses of paraffin-embedded tumour on Vascular endothelial Growth Factor Receptor (VEGFR) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show VEGFR upregulation/downregulation following study intervention
  • Determination of proliferative activity (Ki-67 staining, Cluster of Differentiation 31 protein (CD31) staining) [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show an increase or reduction in proliferation markers Ki67 and CD31 following study intervention
  • Determination of activation of the Deoxyribonucleic acid damage response (DDR) pathway [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumour samples show activation of the DDR pathway following study intervention
  • Wnt/β-catenin proliferation pathway protein expression (e.g. c-myc and cyclinD1 proteins) [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients who show an increase or a decrease in expression of proteins involved in the Wnt/β-catenin proliferation pathway (e.g. c-myc and cyclinD1 proteins) following study intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • Recurrence free survival at 5 years [ Time Frame: 5 years from study randomisation ]
  • Overall survival at 2 and 5 years [ Time Frame: 2 and 5 years from study randomisation ]
  • Colon cancer specific death at 2 and 5 years [ Time Frame: 2 and 5 years from study randomisation ]
  • Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 7 following start of study intervention (artesunate/matching placebo) ]
  • Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 14 following start of study intervention (artesunate/matching placebo) ]
  • Number of patients experiencing artesunate drug related toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 42 following start of study intervention (artesunate/matching placebo) ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 7 following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 14 following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment at Day 42 following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 6 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 12 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 18 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 24 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 30 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 36 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 42 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 48 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 54 months following study intervention ]
  • Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Assessment 60 months following study intervention ]
  • Pathological assessment of tumour regression (involvement of lymph nodes; serosa; resection margin) [ Time Frame: Post surgical pathology review (following Day 14 of study intervention) ]
  • Patient quality of life [ Time Frame: Assessment at Day 1 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment at Day 7 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment at Day 14 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment at Day 42 of study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 6 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 12 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 18 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 24 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 30 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 36 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 42 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Patient quality of life [ Time Frame: Assessment 60 months following study intervention ]
    Using validated quality of life self-administered questionnaires
  • Surgical complications [ Time Frame: From time of surgery up to 3 months post surgery ]
    Number of patients with surgery related adverse events as assessed by CTCAE v4.0
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 1 of study intervention ]
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 7 of study intervention ]
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 14 of study intervention ]
  • Predictive value of tumour marker Carcinoma Embryonic Antigen (CEA) kinetics in terms of predicting response to artesunate therapy [ Time Frame: Assessment at Day 42 of study intervention ]
  • Immunohistochemical analyses of paraffin-embedded tumour sections to assess Kirsten rat sarcoma viral oncogene homolog (Kras) mutation status [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients with Kras mutant tumours
  • Immunohistochemical analyses of paraffin-embedded tumour sections to assess Mismatch Repair (MMR) status [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients with Mismatch Repair (MMR) mutant tumours
  • Immunohistochemical analyses of paraffin-embedded tumour for v-Raf murine sarcoma viral oncogene homolog B (BRAF) mutation status [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients with BRAF mutant tumours
  • Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor (PDGF) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show PDGF upregulation/downregulation following treatment intervention
  • Immunohistochemical analyses of paraffin-embedded tumour for Platelet derived growth factor receptor (PDGFR) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show PDGFR upregulation/downregulation following study intervention
  • Immunohistochemical analyses of paraffin-embedded tumour for Vascular endothelial Growth Factor (VEGF) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show VEGF upregulation/downregulation following study intervention
  • Immunohistochemical analyses of paraffin-embedded tumour on Vascular endothelial Growth Factor Receptor (VEGFR) expression [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show VEGFR upregulation/downregulation following study intervention
  • Determination of proliferative activity (Ki-67 staining, Cluster of Differentiation 31 protein (CD31) staining) [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumours show an increase or reduction in proliferation markers Ki67 and CD31 following study intervention
  • Determination of activation of the Deoxyribonucleic acid damage response (DDR) pathway [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients whose tumour samples show activation of the DDR pathway following study intervention
  • Wnt/β-catenin proliferation pathway protein expression (e.g. c-myc and cyclinD1 proteins) [ Time Frame: Pre and post intervention tumour samples from patients (Day 0 and Day 15) ]
    Number of patients who show an increase or a decrease in expression of proteins involved in the Wnt/β-catenin proliferation pathway (e.g. c-myc and cyclinD1 proteins) following study intervention
  • Determination of cell-free circulating tumour Deoxyribonucleic acid (ctDNA) levels in patient blood plasma samples [ Time Frame: Pre and post intervention blood samples from patients (Day 0 and Day 15) ]
    Number of patients shown to have an increase or a reduction in cell-free circulating tumour Deoxyribonucleic acid (ctDNA) following study intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer
Official Title  ICMJE Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer
Brief Summary

This study evaluates the safety and effectiveness of pre-operative artesunate given orally once a day for 14 days prior to surgery in patients with Stage II/III colorectal cancer.

Artesunate is an established antimalarial drug with an excellent safety profile, is well tolerated and affordable. A number of laboratory studies and one small pilot clinical study in patients with colorectal cancer have shown that artesunate can reduce the proliferation and growth of cancer cells.

Two hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly allocated to receive oral artesunate 200mg daily or a matching placebo for 14 days prior to surgery. Patients will be followed up closely for 5 years to see if giving artesunate preoperatively reduces the risk of cancer recurring after surgery.

Detailed Description

Artesunate is an established antimalarial drug belonging to the artemisinin class of drugs, has an excellent safety profile, is well tolerated and affordable. In last two decades, artemisinins have shown potent and broad anticancer properties in a range of cell lines and animal models, supporting the hypothesis that artemisinins have the potential to be an effective anti-cancer therapy. Multiple potential mechanisms of action include anti-proliferative effects through cell-cycle disruption, reactive oxygen species (ROS) -induced DNA damage, induction of apoptosis, anti-angiogenesis, immunomodulation and induced radiosensitivity.

Despite a multi-modality treatment approach to colorectal cancer, 5 year overall survival does not currently exceed 60%. Neoadjuvant pre-operative therapy may be more effective at eradicating micrometastases compared to adjuvant therapy delivered following the delay and immunological stress of surgery. However current neoadjuvant chemotherapy regimens are often associated with significant side effects and may result in a delay in surgery whilst patients recover. A well tolerated, affordable, novel anticancer agent that could be given to patients whilst they wait for surgery, without causing a surgical delay due to treatment related toxicity, would have a significant clinical impact on patient care.

The NeoART trial is a phase II multicentre randomised, double blind, placebo controlled trial (RCT) for patients undergoing primary surgery for Stage II/III colorectal cancers. Patients are randomised (1:1 ratio) to receive either a two week course of neoadjuvant artesunate 200mg once daily or matching placebo. Both patients and health care professionals are blinded to treatment allocation arm to minimise outcome-reporting bias. The primary endpoint of the trial is recurrence free survival two years after surgery. Secondary endpoints include 2 and 5 year overall survival, treatment related toxicity, tolerability and patient quality of life. A translational sub-study looking at predictive and prognostic biomarkers is also planned.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Bowel Cancer
Intervention  ICMJE
  • Drug: Artesunate 200mg
    Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery
  • Drug: Placebo
    Matched placebo PO OD for 14 days prior to colorectal resection surgery
Study Arms  ICMJE
  • Experimental: Artesunate
    Artesunate 200mg oral tablets once daily for 14 days.
    Intervention: Drug: Artesunate 200mg
  • Placebo Comparator: Matching placebo
    Matching placebo oral tablets once daily for 14 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2025
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Aged 18 or over
  2. Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer
  3. Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy
  4. WHO performance status 0,1 or 2
  5. Adequate full blood count: White Cell Count (WCC) >3.0 x 10^9 /l; Platelets >100 x 10^9/l; Haemoglobin (Hb) >80g/L
  6. Adequate renal function: Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula
  7. Adequate hepatobiliary function : Bilirubin < 3 x Upper limit normal
  8. Female participants of child bearing potential must have a negative pregnancy test < 72 hours prior to initiating study intervention and agree to avoid pregnancy using adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention
  9. Male participants with a partner of childbearing potential must agree to use adequate, medically approved contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention
  10. Patient able and willing to provide written, informed consent for the study.

Exclusion criteria

  1. Contraindication to the use of artesunate due to hypersensitivity
  2. Pregnancy or lactation
  3. Male or female participants unwilling to use an effective method of birth control (either hormonal in the form of contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film); or agreement of true abstinence from time to consent is signed until 6 weeks after the last dose of study treatment intervention (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation methods are not considered acceptable methods)
  4. History of immunosuppression
  5. History of hearing or balance problems
  6. Weight < 52kg or > 110kg
  7. Other planned intervention, apart from standard of care
  8. Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ
  9. Lactose intolerance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Professor Sanjeev Krishna, FRCP, ScD, FMedSci ++44(0)208 725 5836 s.krishna@sgul.ac.uk
Contact: Dr Yolanda Augustin, MBBS, MRCP, FRCR, MSc ++44(0)2087255722 yaugusti@sgul.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02633098
Other Study ID Numbers  ICMJE 15.0154
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St George's, University of London
Study Sponsor  ICMJE St George's, University of London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Professor Devinder Kumar, MBBS, PhD, FRCS St George's University Hospitals NHS Foundation Trust
PRS Account St George's, University of London
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP