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Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)

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ClinicalTrials.gov Identifier: NCT01921998
Recruitment Status : Suspended (Trial has been suspended due to lack of resource and staff)
First Posted : August 14, 2013
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Rebecca Robinson, The Christie NHS Foundation Trust

Brief Summary:

Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.

This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.


Condition or disease Intervention/treatment
Lymphoma Sarcoma Procedure: Biomarker and health economics

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy
Study Start Date : October 2013
Estimated Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Biomarker and health economics
Biomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.
Procedure: Biomarker and health economics
Biomarkers CK18 and FLT3 Ligand will be collected




Primary Outcome Measures :
  1. sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity [ Time Frame: day 3 ]
    to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity


Secondary Outcome Measures :
  1. number of hospital admissions for febrile neutropenia [ Time Frame: end of chemotherapy at approximately 6 months ]
  2. Total number of overnight stays or stays in A&E of over 4 hours spent in hospital [ Time Frame: End of study chemotherapy at approximately 6 months ]
  3. Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy [ Time Frame: End of chemotherapy at approximately 6 months ]
  4. Number of total days delay in receiving chemotherapy treatment compared to planned delivery [ Time Frame: end of chemotherapy at approximately 6 months ]
  5. Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires [ Time Frame: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months) ]
  6. Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors [ Time Frame: end of study chemotherapy at approximately 6 months ]

Biospecimen Retention:   Samples With DNA
Blood samples will be collected to analyse for biomarkers CK18 and FLT 3 Ligand.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.
Criteria

Inclusion Criteria:

  • Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
  • Age 18 or older
  • Performance Status 0-2
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.

Exclusion Criteria:

  • Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
  • Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
  • Radio-immunotherapy within the last 8 weeks.
  • Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921998


Locations
United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
The Christie NHS Foundation Trust
Investigators
Study Chair: Alastair Greystoke The Christie NHS Foundation Trust

Responsible Party: Rebecca Robinson, Clinical Trial Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01921998     History of Changes
Other Study ID Numbers: 11_DOG05_99
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015