Recruiting

MiRNA

Sponsor:

University of Southern California

Code:

NCT06060873

Conditions

Malignant Testicular Germ Cell Tumor

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Stage I Disease

Clinical Stage I with relapse, CSII Disease

Study Details

Brief summary:

This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.

Conditions

Malignant Testicular Germ Cell Tumor

Study ID

NCT06060873

Start date

Jun 8, 2023

Status verified date

Aug, 2026

Completion date

Dec 8, 2028

Anticipated

Primary completion date

Jun 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

418 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

This cohort involves all CS-I GCT patients which is defined as GCT in orchiectomy specimen (seminoma and NSGCT), normal conventional staging imaging, and normal/low stable tumor markers. The current standard of care for management of CS-I disease is either surveillance, RPLND, or systemic therapy. Surveillance is preferred however is largely dependent on clinician discretion. In this cohort miRNA-371 level will be drawn at any timepoint after orchiectomy. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years.

Cohort 2

This cohort involves all GCT patients with radiographically enlarged retroperitoneal lymph nodes <3 cm (initial CS-I GCT patients with radiographic evidence of retroperitoneal lymph node enlargement and de-novo CS-II patients). In this cohort, miRNA-371 level will be drawn at any timepoint after orchiectomy. Patients with initial CS-I and retroprertioneal relapse/ de-novo CS-II disease and normal miRNA-371 levels will undergo reassessment (repeat cross sectional imaging and miRNA level) after 6 weeks. If mass is stable and miRNA-371 level remains normal then patients will continue on surveillance. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years.

Interventions

Clinical Stage I Disease

Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or standard surveillance. Surveillance will follow until year 5.

Clinical Stage I with relapse, CSII Disease

Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or reassessment and then surveillance will follow until year 5.

Primary outcome measure

  • Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy [ Time Frame: Through study completion, up to 5 years ]

Central Contacts and Locations

Central contacts

Ileana Aldana

323-865-0702Ileana.Aldana@med.usc.edu

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Alisha Hitt

205-539-2908aghitt@uabmc.edu

Principal Investigator:

Charles Peyton, MD

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92530

Contacts

Tiffany Sanchez

909-558-7251TISanchez@llu.edu

Principal Investigator:

Alsyouf Muhannad, MD

Los Angeles County-USC Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ileana Aldana

323-865-0702Ileana.Aldana@med.usc.edu

Principal Investigator:

Siamak Daneshmand, MD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ileana Aldana, MD

323-865-0702Ileana.Aldana@med.usc.edu

Principal Investigator:

Siamak Daneshmand, MD

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sophie Kim

404-778-4898sophie.kim@emory.edu

Sierra Thomson

404-778-4898sierra.williams@emory.edu

Principal Investigator:

Viraj Master, MD

Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Alicia Moore

732-609-1144aca108@cinj.rutgers.edu

Principal Investigator:

Thomas Jang, MA

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Rida Khan

(416) 946-4501rida.khan2@uhn.ca

Stephen Cox

stephen.cox3@uhn.ca

Principal Investigator:

Robert Hamilton, MD

More Information

Sponsor

University of Southern California

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-08-20.