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Diagnostic and Prognostic Value of Liquid Biopsy in Germ Cell Tumors
Sponsor study identifier
observational
200
0 countries
N/A
Study Start
February 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Theoretical framework: Testicular germ cell tumors (TGCT) are characterized by frequent chromosomal anomalies such as gain of chromosome 12p and low rates of somatic mutations. Cell-free circulating tumor DNA (ctDNA) has been investigated in some cancers but only a few studies explored the presence of ctDNA in TGCT. The consistent gain of genetic material from chromosome 12p makes TGCT patients to ideal candidates for liquid biopsy investigations. We have analyzed three pre-chemo samples with our plasma-Seq approach and applied the ichorCNA algorithm to call for somatic copy number alterations (SCNA) and estimate the tumor fraction. Besides the frequently observed chromosome 12p gain, a variety of other SCNA were detected indicating that shallow whole genome sequencing (sWGS) is a suitable approach to analyze ctDNA in TGCT. Only 60% of TGCT patients express the classical markers alpha fetoprotein (AFP) and beta (human chorionic gonadotropin) HCG. Biomarkers to monitor patients who don't express the classical markers are of great need. Hypotheses: We postulate that tumor-specific aberrations can be detected non-invasively in plasma DNA from patients with metastatic TGCT and serve as a diagnostic tool. Furthermore, we will investigate if the change of ctDNA during curative treatment can be used as monitoring tool and allows risk classification in comparison to conventional markers and the novel micro RNA biomarker miR-371a-3p (prognostic value of ctDNA). Methods: For ctDNA and micro RNA analysis, blood samples will be drawn from patients before orchiectomy, before chemotherapy start, prior to the second cycle of chemotherapy, after completion of treatment and in case of relapse. In order to identify SCNA and to estimate the tumor content in plasma we will employ sWGS and analyze the data with the ichorCNA algorithm for a detection of SCNA. Since TGCT have low rates of somatic mutations, orchiectomy samples from patients with disease recurrence and plasma samples at time of recurrence will also be compared with the Biomodal platform which allows analysis of genetic as well as epigenetic changes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2026
Actual (reported)January 29, 2026
Actual (reported)February 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of patients with detectable ctDNA
2 years
To compare the sensitivity and specificity of ctDNA with miR-371a-3p
2 years
non-metastatic testicular germ cell tumors
metastatic testicular germ cell tumors
We aim to recruit 200 testicular germ cell tumor patients, 100 subjects with metastatic disease and 100 patients with stage I disease.
ctDNA and microRNA
First Submitted
January 22, 2026
First Posted
January 29, 2026
Study Start
February 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 15, 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 29, 2026
Record last verified: 2026-01
The publication underlying data will be published in zenodo under a CC BY license. The data will get a DOI through data publication in zenodo and will be referenced in the publication´ s data availability statement.
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Source: ClinicalTrials.gov.
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