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Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment (EMIT)

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ClinicalTrials.gov Identifier: NCT03980587
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
University College London (UCL) Cancer Institute
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Tracking Information
First Submitted Date April 29, 2019
First Posted Date June 10, 2019
Last Update Posted Date June 10, 2019
Estimated Study Start Date August 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2019)
  • Circulating DNA in plasma is measurable [ Time Frame: 1 year ]
    Measurement of plasma of patients with platinum refractory/resistant germ cell tumours
  • Exploratory analysis of circulating DNA [ Time Frame: 1 year ]
    1. describe the molecular aberrations in plasma from metastatic germ cell tumours with platinum resistant/refractory disease
    2. Describe aberrations detected in sequential samples from the same indivivdual patient and evaluate whether there are hypothesis-generating changes that temporally associate with clinical resistance
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment
Official Title Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment
Brief Summary
  1. To establish whether circulating tumour DNA is detectable in the plasma of patients with platinum refractory/resistant Germ Cell Tumours
  2. If ctDNA is detectable, perform exploratory analyses to:

    1. Describe the molecular aberrations in plasma from metastatic GCTs with platinum refractory/resistant disease
    2. Describe aberrations detected in sequential detected in sequential samples form the same individual patient and evaluate whether there are hyposthesis-generating changes that temporarily associate with clinical resistance.
Detailed Description This project will study the plasma of patients who have metastatic GCTs with platinum refractory/resistant disease in order to establish if ctDNA is detectable and then analyse the molecular aberrations. Archival diagnostic tissue will be recalled (this is the tissue used to make the initial diagnosis of testicular cancer). Excess tissue acquired from clinically mandated prospective biopsies will be stored and plasma which has been collected at a maximum of 15 time-points per year will be analysed. Clinical data will be accessed to make clinically meaningful associations with plasma and tissue molecular aberrations.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood samples have been collected and stored in Royal Marsden Biobank. Archived tumour samples may also be used.
Sampling Method Non-Probability Sample
Study Population

Patients will have consented to the collection and storage of blood samples and archival tissue at the RMH bio-bank. Testicular cancer management is focused in a single multidisciplinary clinic (Sutton Friday AM) and is the centre for follow up of these patients. We propose to initially analyseclinical material from 18 patients who have attended this clinic. To meet our primary objective, patient samples will be selected based on the burden of metastatic tumour in the patient at the time of the blood sample. Samples will be selected from patients at the latest available time-point in their disease process where the disease burden was at its highest.

The minimum sample requirement for our primary and secondary objectives is a blood sample taken during at least one timepoint. However if there are an excess of patients with bloods samples collected when metastatic disease burden is at its highest, patient samples will be preferentially selected if they have sequential samples.

Condition Testicular Germ Cell Tumor
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: June 7, 2019)
18
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with histologically confirmed metastatic GCT refractory/resistant to platinum treatment
  • Patients who have signed the 'Tissues for Research' consent form at the Royal Marsden Hospital and have blood samples stored in the RMH Biobank.
  • Patients with no prior or current non-testicular invasive malignancy within the last 3 years, other than non-melanoma skin cancer or NCCN low risk prostate cancer (pT1 or pT2a Gleason ≤ 6, PSA ≤ 10 and ≤ 1cc total volume)

Exclusion Criteria:

  • n/a
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Reid 0208 6426011 ext 4319 alison.reid@rmh.nhs.uk
Contact: Jenni Parmar 0208 6113070 jenni.parmar@rmh.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03980587
Other Study ID Numbers CCR4911
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
Plan to Share IPD: Undecided
Responsible Party Royal Marsden NHS Foundation Trust
Study Sponsor Royal Marsden NHS Foundation Trust
Collaborators University College London (UCL) Cancer Institute
Investigators
Principal Investigator: Alison Reid Royal Marsden NHS Foundation Trust
PRS Account Royal Marsden NHS Foundation Trust
Verification Date March 2019