SWOG clinical trial number
S1823

A Prospective Observational Cohort Study to Assess miRNA371 for Outcome Prediction in Patients with Early Stage Germ Cell Tumors

Open
Accrual
24%
Abbreviated Title
miRNA 371 Study in Germ Cell Tumors
Activated
06/01/2020
Participants
CTSU, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCORP COMPONENTS AND SUBCOMPONENTS

Research committees

Prevention & Epidemiology
Genitourinary Cancer

Eligibility Criteria Expand/Collapse

Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/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 be >/= 18 years of age; 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; 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 lab evaluations beta-HCG, AFP, and LDH; Ideally, patients should be willing to return to their center performing surveillance (registering site) for the duration of the study to ensure that specimens are timed to standard clinical observations (the registering site's surveillance schedule). Patients must be offered participation in specimen banking for future research

Publication Information Expand/Collapse

2019

Developing a Highly Specific Biomarker for Germ Cell Malignancies: Plasma miR371 Expression Across the Germ Cell Malignancy Spectrum

L Nappi;M Thi;A Lum;D Huntsman;B Eigl;C Martin;B O'Neil;B Maughan;K Chi;A So;P Black;M Gleave;A Wyatt;J Lavoie;D Khalaf;R Bell;S Daneshmand;R Hamilton;R Leao;C Nichols;C Kollmannsberger Journal of Clinical Oncology, Nov 20;37 (33), 3090-3098

PMid: PMID31553692 | PMC number: PMC7351323

Validation of plasma miR-371a-3p expression in patients with metastatic and early stage germ cell tumor

L Nappi;M Thi;A Lum;D Huntsman;B Eigl;K Chi;C Martin;B O'Neil;B Maughan;A So;P Black;M Gleave;A Wyatt;J Lavoie;D Khalaf;S Daneshmand;R Hamilton;R Leao;C Nichols;C Kollmannsberger J Clin Oncol 37, 2019 (suppl 7S; abstr 526), poster; ASCO GU Cancers Symposium

Reports & Approvals

Trial Locations

Other Clinical Trials

SWOG Clinical Trial Number
CTSU/A031901
SWOG Clinical Trial Number
CTSU/EA8185