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A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors
 
Region Sponsors
California - Northern
SWOG Cancer Research Network
 
Acronym KP IRB No.
S64
 
Study Type Phase
Other Observational Study with Direct Patient Contact
 
Study Population Description
 
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
 
Gender Age Limit
Male & Female
 
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)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Andrea Harzstark
Contact Information:
- Desiree Goldstein
-ctpcollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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