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A Study of miRNA 371 in Patients With 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
Southwest Oncology Group
Acronym KP IRB No.
Study Type Phase
Other Observational Study with Direct Patient Contact
Study Population Description
(Adult, Older Adult) Male and Female with Germ Cell Tumor, Malignant Neoplasm Seminoma, Stage I Testicular Cancer AJCC v8, Stage IA Testicular Cancer AJCC v8, Stage IB Testicular Cancer AJCC v8, Stage IS Testicular Cancer AJCC v8
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
PRIMARY OBJECTIVE: I. To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy. SECONDARY OBJECTIVES: I. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data. II. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531. OUTLINE: Patients undergo collection of blood every 3-6 months for up to 3 years.
Gender Age Limit
Male & Female 18 years & older
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)
  • Please contact study team for additional inclusion criteria
Exclusion Criteria
  • Please contact study team for exclusion criteria:

Keywords and/or Specific Medical Conditions
  • Endocrine Gland Neoplasms
  • Neoplasms by Site
  • Endocrine System Diseases
  • Neoplasms, Germ Cell and Embryonal
  • Genital Neoplasms, Male
  • Seminoma
  • Germinoma
  • Testicular Diseases
  • Gonadal Disorders
  • Testicular Neoplasms
  • Neoplasms
  • Urogenital Neoplasms
  • Neoplasms by Histologic Type
  • Oncology (Adult)
KP Clinical Facility
  • Central Interstate Medical Office
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Abdul Hai Mansoor, MD
Contact Information:
- Susan J Granat
-Central Interstate Medical Office

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