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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 18

Contacts and Locations

• Study Contact: Name: Reid; Phone Number: 4319 0208 6426011; Email: alison.reid@rmh.nhs.uk
• Study Contact Backup: Name: Jenni Parmar; Phone Number: 0208 6113070; Email: jenni.parmar@rmh.nhs.uk

Study Locations

• United Kingdom
  • Surrey
    • London Borough of Sutton, Surrey, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden NHS Trust
      • Contact: Gandolfi; Phone Number: 0208 8642661; Email: ann.gandolfi@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating DNA in plasma is measurable	Measurement of plasma of patients with platinum refractory/resistant germ cell tumours	1 year
Exploratory analysis of circulating DNA	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	1 year

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: University College London (UCL) Cancer Institute
• Investigators: Principal Investigator: Alison Reid, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: ctDNA
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: CCR4911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No