An observational study in Testicular Germ Cell Tumor, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to male participants. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
If ctDNA is detectable, perform exploratory analyses to:
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.
291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.
This study's planned enrollment of 18 is below the median of 214 across 50 observational studies indexed under Neoplasms, Germ Cell and Embryonal.
Browse Neoplasms, Germ Cell and Embryonal studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.
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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.
Exclusion Criteria:
Circulating DNA in plasma is measurable
Measurement of plasma of patients with platinum refractory/resistant germ cell tumours
Time frame: 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
Time frame: 1 year
Plan to share: Undecided
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Neoplasms, Germ Cell and Embryonal→
Royal Marsden NHS Foundation Trust