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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03980587
Acronym
EMIT
Enrollment
18
Registered
2019-06-10
Start date
2019-08-31
Completion date
2021-08-31
Last updated
2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Germ Cell Tumor

Keywords

ctDNA

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.

Interventions

None listed

Sponsors

University College London (UCL) Cancer Institute
CollaboratorOTHER
Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Circulating DNA in plasma is measurable1 yearMeasurement of plasma of patients with platinum refractory/resistant germ cell tumours
Exploratory analysis of circulating DNA1 year1. 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

Countries

United Kingdom

Contacts

Primary ContactReid
alison.reid@rmh.nhs.uk0208 6426011
Backup ContactJenni Parmar
jenni.parmar@rmh.nhs.uk0208 6113070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026