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

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT03980587
Collaborator
University College London (UCL) Cancer Institute (Other)
18
Enrollment
1
Location
24
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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:

  3. Describe the molecular aberrations in plasma from metastatic GCTs with platinum refractory/resistant disease

  4. 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    18 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment
    Anticipated Study Start Date :
    Aug 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Aug 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Circulating DNA in plasma is measurable [1 year]

      Measurement of plasma of patients with platinum refractory/resistant germ cell tumours

    2. Exploratory analysis of circulating DNA [1 year]

      describe the molecular aberrations in plasma from metastatic germ cell tumours with platinum resistant/refractory disease 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Marsden NHS Trust London Borough of Sutton Surrey United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust
    • University College London (UCL) Cancer Institute

    Investigators

    • Principal Investigator: Alison Reid, Royal Marsden NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Marsden NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03980587
    Other Study ID Numbers:
    • CCR4911
    First Posted:
    Jun 10, 2019
    Last Update Posted:
    Jun 10, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Royal Marsden NHS Foundation Trust
    ctDNA
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal

    Study Results

    No Results Posted as of Jun 10, 2019