A Study of miRNA 371 in Patients With Germ Cell Tumors (NCT04435756) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of miRNA 371 in Patients With Germ Cell Tumors
United States956 participantsStarted 2020-07-28
Plain-language summary
This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a new diagnosis of a germ cell tumor. confirmed pathologically or serologically (diagnostic elevation of human chorionic gonadotropin \[HCG\]/alpha-fetoprotein \[AFP\]). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible
* If surgery is planned, male patients with clinical stage I testicular cancer must have orchiectomy completed within 42 days prior to registration
* Patients must be registered within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease
* Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected
* Patients must have beta-human chorionic gonadotropin (beta- HCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration
* NOTE: If the patient had an orchiectomy prior to registration, report tumor marker values before and after surgery on the Baseline Tumor Marker form
* Patients must have risk of relapse assessment determined by the local investigator prior to registration
* Patients must agree to submit required specimens for defined translational medicine studies. These specimens are drawn at the same time as standard laboratory evaluations (beta-HCG, AFP, and LDH); NOTE: Ideally, …
What they're measuring
1
To estimate positive predictive value of miRNA 371 in early stage testicular seminoma and nonseminoma patients
Timeframe: Up to 3 years
2
To bank blood specimens of patients at low risk and moderate risk of relapse