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

NCT03980587 | Unknown DMC

• 1 other identifier: CCR4911
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To establish whether circulating tumour DNA is detectable in the plasma of patients with platinum refractory/resistant Germ Cell Tumours
2. 2.If ctDNA is detectable, perform exploratory analyses to:
3. 3.Describe the molecular aberrations in plasma from metastatic GCTs with platinum refractory/resistant disease
4. 4.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.

Conditions

Testicular Germ Cell Tumor

Keywords

ctDNA

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 year

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• n/a

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• University College London (UCL) Cancer Institute: collaborator

Study Sites (1)

Royal Marsden NHS Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples have been collected and stored in Royal Marsden Biobank. Archived tumour samples may also be used.

MeSH Terms

Conditions

Testicular Germ Cell Tumor

Study Officials

• Alison Reid

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reid

CONTACT

0208 6426011; alison.reid@rmh.nhs.uk

Jenni Parmar

CONTACT

0208 6113070; jenni.parmar@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: June 10, 2019
• Study Start: August 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2021
• Last Updated: June 10, 2019

Record last verified: 2019-03

Locations

GB (1)