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A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors

NCT No.: NCT04435756

Study Type: Clinical Trial

Phase: n/a

Region: California - Northern

Acronym: 

Official Title

A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors

Purpose

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.

Detailed Description

Sex

Male & Female

Age Limit

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
  • 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

Exclusion Criteria

  • N/A

Keywords and/or Specific Medical Conditions

  • Oncology (Adult)
  • Other

Sponsors

  • SWOG Cancer Research Network

Clinical Area

  • Oncology (Adult)
  • Other

Principal Investigator

Andrea Harzstark  

Contact Information

 - Desiree S Goldstein
- CTPCollaborate@kp.org
- Central Valley-Manteca

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