Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors

Conditions

• Germ Cell Cancer Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Whole blood for ctDNA — DIAGNOSTIC_TEST
  Whole blood for ctDNA

Study Details

This study will evaluate the utility of ctDNA detection in patients with high-risk stage I, stage II, and stage III germ cell tumor disease to develop a tool for post-treatment cancer cell detection.

Key Dates

Start date

May 31, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2032

Completion

Dec 31, 2032

Study Design

Enrollment

130 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Cohort I - High Risk Clinical stage I
  50 subjects will be enrolled with high-risk stage I seminomatous or non-seminomatous germ cell tumors. In these patients, ctDNA will be collected post-orchiectomy prior to initiation of surveillance and every 4 months during surveillance for up to 2 years.
• Experimental: Cohort II- Clinical stage II
  30 patients will be enrolled with clinical Stage II seminomatous or non-seminomatous germ cell tumor who are planning to undergo primary resection with RPLND. In these patients, ctDNA will be collected prior to surgery and every 4 months after surgery for up to 2 years.
• Experimental: Cohort III- Clinical stage III
  50 patients will be enrolled with clinical Stage III (or IS) seminomatous or non-seminomatous germ cell tumor who are planning to undergo first-line chemotherapy. In these patients, ctDNA will be collected prior to chemotherapy, at cycle 2 day 1, within 28 days of starting last cycle of chemotherapy, and every 4 months after completing chemotherapy.

Primary Outcome Measure

Positive predictive value (PPV) of circulating tumor DNA in Cohort I [ Time Frame: At screening and every 4 months up to 2 years ]

Central Contacts

• Kathleen Moore, BA
  317-274-0930
  [email protected]

Locations (1)

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