PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
NCT ID: NCT04995198
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2021-05-03
2036-02-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will be recruited \& screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Health. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Health will be scheduled to discuss the results.
Participants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (PRO) measures.
PROMISE Registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data.
Participants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants.
Eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. Participants will be followed for a minimum of 15 years.
The PROMISE registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. Ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for.
For more information, visit the study website at: prostatecancerpromise.org
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
NCT06320223
Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer
NCT01013129
Men at High Genetic Risk for Prostate Cancer
NCT03805919
Magnetic Resonance Imaging and Spectroscopy of the Prostate
NCT00590993
Prostate Cancer Genetic Risk Evaluation and Screening Study
NCT05129605
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with at least one germline pathogenic/likely pathogenic variant
No interventions assigned to this group
Participants with at least one variant of uncertain significance
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* tissue biopsy, and/or
* PSA greater than 100 ng/dL (1ng/ml), and/or
* clear radiographic evidence of disease
* Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)
Exclusion Criteria
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Fred Hutchinson Cancer Center
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Advancing Cancer Treatment, Inc.
UNKNOWN
Prostate Cancer Clinical Trials Consortium
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heather Cheng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Channing Paller, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Channing Paller, MD
Role: primary
Heather Cheng, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
PROMISE Study Site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
c19-235
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.