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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

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.

Condition or disease
Testicular Germ Cell Tumor

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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2021



Primary Outcome Measures :
  1. Circulating DNA in plasma is measurable [ Time Frame: 1 year ]
    Measurement of plasma of patients with platinum refractory/resistant germ cell tumours

  2. 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


Biospecimen Retention:   Samples With DNA
Whole blood samples have been collected and stored in Royal Marsden Biobank. Archived tumour samples may also be used.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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

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): NCT03980587


Contacts
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Contact: Reid 0208 6426011 ext 4319 alison.reid@rmh.nhs.uk
Contact: Jenni Parmar 0208 6113070 jenni.parmar@rmh.nhs.uk

Locations
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United Kingdom
Royal Marsden NHS Trust Recruiting
London Borough of Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Gandolfi    0208 8642661    ann.gandolfi@rmh.nhs.uk   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
University College London (UCL) Cancer Institute
Investigators
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Principal Investigator: Alison Reid Royal Marsden NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03980587    
Other Study ID Numbers: CCR4911
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms