- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07690579
Social, Structural, and Lifestyle Drivers of Prostate Cancer Disparities
Prostate Cancer (PC) is the most common non-cutaneous malignancy diagnosed and second leading cause of cancer death among men across the United States. PC among Black men accounts for a higher proportion alike of cancer diagnoses and deaths. In the prostate specific antigen (PSA)-based screening era, mortality rates improved at a similar velocity among Black and White men, but the 2- to 3-fold excess mortality burden borne by Black men has persisted over the past 40 years, the second highest among all major cancers. In recent years mortality is rising among Black men, and at a rapid velocity.
The explanations for this disparity-the extent to which it is attributable to genetics, environmental factors including Structural and Social Determinants of Health (SSDH), or access to care-are multifactorial and have been elucidated to a limited extent. A large meta-analysis recently found that across dozens of studies and cohorts, greater adjustment for clinical and SSDH factors generally resulted in race itself dropping as a significant predictor.
These and other findings suggest that the determinants of disparity be identified at time of, and prior to, cancer diagnosis, and that both genetic and environmental factors contribute to earlier development and progression.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
The investigators hypothesize that SSDH factors drive cancer development differentially by race, and including SSDH factors in prediction models can improve risk prediction to guide decision-making regarding screening, diagnosis, and treatment across race and ethnic groups.
PRIMARY OBJECTIVE:
To identify not yet discovered SSDH and lifestyle factors that associate with identification of unfavorable vs. favorable prostate cancer histology between Black, Hispanic, and Asian men.
OUTLINE:
UCSF participants who agreed to participate in the Urology 90991 Biobank Consent (UCSF internal review board (IRB) #11-05226), and urology surgeons at community hospitals may refer participants for radical prostatectomy to University of California, San Francisco. Potential participants will be approached by the UCSF study team for an offer to participate and Non-UCSF participants will be asked to sign a medical release form prior to the research team collecting data from your medical record about your prostate cancer and treatment.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Kiana Washington
- Telefonnummer: 415.514.8026
- E-post: Kiana.Washington@ucsf.edu
Studera Kontakt Backup
- Namn: Karina Acevedo
- Telefonnummer: 415.353.7615
- E-post: Karina.Acevedo@ucsf.edu
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94143
- Rekrytering
- University of California, San Francisco
-
Kontakt:
- Kiana Washington
- Telefonnummer: 415.514.8026
- E-post: Kiana.Washington@ucsf.edu
-
Kontakt:
- Karina Acevedo
- Telefonnummer: 415.353.7615
- E-post: Karina.Acevedo@ucsf.edu
-
Huvudutredare:
- Mathew Cooperberg, MD, MPH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Participants who have elected radical prostatectomy as prostate cancer treatment.
- Participants who have agreed to participate in the Urology Biobank.
Exclusion Criteria:
- Participant does not plan nor schedule a radical prostatectomy (RP) procedure.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Men with prostate cancer
Participants who have planned or completed a non-investigational radical prostatectomy will be asked to complete a series of questionnaires online covering a subset of community-informed SSDH measures and individual exposures.
Responses will be recorded in a secured database. .
It will take about up to 2 hours to complete the surveys.
There will be questions about your demographics (education level, income, employment, etc.); health care access and quality; lifestyle and behaviors.
Data from your medical record about your prostate cancer and treatment will also be collected.
|
Participants will receive surveys to complete online via a secure system.
Andra namn:
Data will be collected from participants medical charts which includes disease history, pathological findings, and other disease characteristics.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Identification of not yet identified factors contributing to prostate cancer
Tidsram: Up to 2 years
|
Genomic and SSDH factors will be evaluated to locate not yet identified factors that are associated with greater immune activation and prediction of unfavorable vs. favorable prostate cancer biology by race and ethnicity groups.
|
Up to 2 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Matthew Cooperberg, MD, University of California, San Francisco
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Prostatiska neoplasmer
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Epidemiologiska metoder
- Datainsamling
- Hälsovårdsutvärderingsmekanismer
- Hälsovårdskvalitet
- Folkhälsa
- Miljö och folkhälsa
- Undersökningar och frågeformulär
Andra studie-ID-nummer
- 255517
- U54CA302452 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
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