RECRUITING

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer

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Conditions

Prostate CancerBiomarkersActive surveillanceGene Expression Classifier

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.

Official Title

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer

Quick Facts

Study Start:2020-11-05
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04396808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
  2. * Prostate biopsy tumor tissue (FFPR block) available for processing
  3. * Age 18 years or older
  4. * PSA \<20 ng/ml
  5. * Grade Group (GG) 1 cancer with \> 2 biopsy cores involved with cancer OR GG2 cancer
  6. * Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.
  1. * Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
  2. * Nodal or metastatic prostate cancer (if staging imaging performed)
  3. * Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
  4. * Prior prostate gene expression classier testing

Contacts and Locations

Study Contact

G-Major Study
CONTACT
734-764-4060
gmajorstudy@med.umich.edu

Principal Investigator

Todd Morgan, M.D.
PRINCIPAL_INVESTIGATOR
University of Michigan
Daniel Spratt, M.D.
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Sherwood Medical Center
Detroit, Michigan, 48221
United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503
United States
Western Michigan Urological Associates
Holland, Michigan, 49423
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Todd Morgan, M.D., PRINCIPAL_INVESTIGATOR, University of Michigan
  • Daniel Spratt, M.D., PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-05
Study Completion Date2025-07

Study Record Updates

Study Start Date2020-11-05
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Biomarkers
  • Active surveillance
  • Gene Expression Classifier

Additional Relevant MeSH Terms

  • Prostate Cancer