Clinical trial · Interventional
Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
NCT07401316CI-TRIAL-00114685recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole blood for ctDNA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort I - High Risk Clinical stage I
- description
- 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.
- interventionNames
- Diagnostic Test: Whole blood for ctDNA
- type
- EXPERIMENTAL
- label
- Cohort II- Clinical stage II
- description
- 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.
- interventionNames
- Diagnostic Test: Whole blood for ctDNA
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Subjects must have histologically or serologically confirmed seminomatous or non seminomatous germ cell tumor. Non-seminoma includes embryonal carcinoma, choriocarcinoma, yolk sac tumor, or teratoma. Note: Cohort I is for high-risk clinical stage I disease (high risk will be defined as per enrolling investigator discretion). Cohort II is for clinical stage II. Cohort III is for clinical stage III or IS. 4. Archival tissue for germ-cell tumor diagnosis available Exclusion Criteria: 1. Concurrent disease or condition that would make the subject inappropriate for study participation 2. Any serious medical disorder that would interfere with the subject's safety 3. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent per treating physician coverage. 4. Patient is being tested for minimal residual disease with other experimental platforms
References
Publications (0)
Data not yet available
No reference posted for this study.