Using blood tests to detect active testicular cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the accuracy of the blood-based biomarker miRNA-371 in predicting the presence of active malignant testicular germ cell tumors before surgery. Patients will have blood samples collected during screening and throughout the study, with those showing elevated miRNA-371 levels proceeding to standard surgery. Those with normal levels will undergo surveillance until their levels rise. The study aims to improve pre-operative detection of testicular cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)
* Clinical stage of patient is either:

  * Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA/B pure seminoma
  * Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA/B NSGCT
* For subjects with retroperitoneal lymphadenopathy: no lymph node \>3 cm in greatest dimension with no more than 2 nodes enlarged
* Axial abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 3 months of enrollment if stage I patient
* Axial abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 8 weeks of enrollment if stage II patient
* miRNA-371 can be drawn and sent for analysis at time of consent
* Enrollment within 1 year after orchiectomy for stage I patients
* Enrollment at any timepoint after orchiectomy for stage II patients
* Retroperitoneal lymphadenopathy must be within an RPLND template
* Biopsy of lymph node is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with GCT
* Serum Alpha Feto Protein (AFP) \<50 ng/ml, β-Human Chorionic Gonadotropin (β-HCG) 25 mIU/ml within 42 days (6 weeks) of enrollment
* Age ≥ 18 years
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Second primary malignancy
* Patients receiving any other investigational agent (s)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• Loma Linda University Medical Center
  Loma Linda, California, United States Recruiting
• Los Angeles County-USC Medical Center
  Los Angeles, California, United States Recruiting
• USC / Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Siamak Daneshmand, MD — University of Southern California
• Study coordinator: Ileana Aldana
• Email: Ileana.Aldana@med.usc.edu
• Phone: 323-865-0702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.