Circulating Tumor Dna in High-Risk Stage I and Clinical Stage II Germ-Cell Tumors

Study on Tumor DNA in Germ Cell Tumors

N
Nabil Adra, MD

Primary Investigator

Recruiting
18 years - 100 years
All
Phase N/A
75 participants needed
1 Location

Brief description of study

Circulating tumor DNA (ctDNA) is a biomarker that shows how well the body responds to treatment for a disease. Blood and tissue specimens will be collected from patients to find out whether ctDNA can be detected in those specimens so that tools can be developed to predict the presence (or absence) of ctDNA after cancer treatment.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

This is a specimen collection study where patients with high-risk stage I germ cell tumor and those with clinical stage II germ cell tumor will be evaluated for ctDNA.  

Cohort I - High Risk Clinical stage I seminoma/non-seminoma (N=50):  
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. 

Cohort II- Clinical stage II seminoma/non-seminoma (N=30):  
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.

Cohort III- Clinical stage III (or IS) seminoma/non-seminoma (N=50):  
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, and every 4 months after completing chemotherapy. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Germ-Cell Tumor, Cancer
  • Age: 18 years - 100 years
  • Gender: All

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. 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. 
 

This study investigates circulating tumor DNA (ctDNA) in patients with high-risk stage I and clinical stage II germ cell tumors. Circulating tumor DNA is a biomarker that helps show how the body responds to cancer treatments. By collecting blood and tissue samples, researchers aim to see if ctDNA can be detected in these specimens. This could help develop tools to predict ctDNA presence after cancer treatment.

In this study, patients will have blood samples taken at different times depending on their treatment stage. For those with high-risk stage I tumors, ctDNA will be collected after surgery and during regular check-ups. For clinical stage II tumors, samples will be taken before and after surgery. For stage III, samples will be collected before and during chemotherapy, and regularly afterward.

  • Who can participate: Adults aged 18 and older with confirmed seminomatous or non-seminomatous germ cell tumors can participate. Participants must provide written consent and have available tissue samples for diagnosis.
  • Study details: Participants will provide blood samples at specific times based on their treatment stage. These samples are used to detect ctDNA, a biomarker for cancer treatment response.
  • Study timelines: The study will last 2 years.
Updated on 27 Apr 2026. Study ID: CTO-IUSCCC-0937, 28511

Find a site

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the Study Team