A Study of MiRNA 371 in Patients with Germ Cell Tumors

Recruiting at 442 trial locations

Overseen By Patricia O'Kane

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SWOG Cancer Research Network

Disqualifiers: Other cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

956 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Craig R Nichols

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Patients undergo collection of blood every 3-6 months to assess miRNA 371 for outcome prediction

Up to 3 years

Blood collection every 3-6 months

Follow-up

Participants are monitored for safety and effectiveness after observational period

6 months

Treatment Details

Interventions

• Blood Product Collection

Participant Groups

Group I: Observational (blood collection) Experimental Treatment 2 Interventions

Patients undergo collection of blood every 3-6 months for up to 3 years.

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+