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

Testicular Germ Cell Tumor Clinical Trial

— EMIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980587
• Other study ID #: CCR4911
• Status: Recruiting
• Start date: August 2019
• Est. completion date: August 2021

Study information

• Verified date: March 2019
• Source: Royal Marsden NHS Foundation Trust
• Contact: Reid
• Phone: 0208 6426011
• Email: alison.reid[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: August 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Trust	London Borough of Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	University College London (UCL) Cancer Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating DNA in plasma is measurable	Measurement of plasma of patients with platinum refractory/resistant germ cell tumours	1 year
Primary	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