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

Testicular Germ Cell Tumor Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

• NCT number: NCT03980587
• Study type: Observational
• Source: Royal Marsden NHS Foundation Trust
• Contact: Reid
• Phone: 0208 6426011
• Email: alison.reid@rmh.nhs.uk
• Status: Recruiting
• Start date: August 2019
• Completion date: August 2021