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

• Conditions: Testicular Germ Cell Tumor

• Registration Number: NCT03980587
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10
• Study Start: 2019-08
• Primary Completion: 2020-03
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating DNA in plasma is measurable	1 year	Measurement of plasma of patients with platinum refractory/resistant germ cell tumours
Exploratory analysis of circulating DNA	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

Trial Locations

Locations (1)

Royal Marsden NHS Trust; 🇬🇧 London Borough of Sutton, Surrey, United Kingdom