Blood test may spot active testicular cancer, study seeks proof
NCT ID NCT06060873
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times
Summary
This study is testing whether a blood test that measures a substance called miRNA-371 can accurately detect active testicular cancer in people who have already had their primary tumor removed. Researchers will compare the blood test results with surgical findings to see how well the test predicts cancer presence. The study involves 418 participants and aims to improve detection and reduce unnecessary procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 418 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with testicular germ cell tumor
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University Hospital/Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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Loma Linda University Medical Center
RECRUITINGLoma Linda, California, 92530, United States
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Los Angeles County-USC Medical Center
RECRUITINGLos Angeles, California, 90033, United States
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Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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USC / Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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University Health Network
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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University of Alabama at Birmingham Cancer Center
RECRUITINGBirmingham, Alabama, 35233, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Glowing dye could reveal hidden cancer spread in testicular tumors
- New antibody drug enters first human tests for tough cancers
- Blood marker may outshine scans for testicular cancer detection
- Super MRI scans peek inside brains of testicular cancer survivors
- New drug duo hopes to boost immune system against tough cancers
- Scientists hunt for testicular cancer genes in families