- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Kiana Washington
- Telefonnummer: 415.514.8026
- E-post: Kiana.Washington@ucsf.edu
Studer Kontakt Backup
- Navn: Karina Acevedo
- Telefonnummer: 415.353.7615
- E-post: Karina.Acevedo@ucsf.edu
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94143
- Rekruttering
- University of California, San Francisco
-
Ta kontakt med:
- Kiana Washington
- Telefonnummer: 415.514.8026
- E-post: Kiana.Washington@ucsf.edu
-
Ta kontakt med:
- Karina Acevedo
- Telefonnummer: 415.353.7615
- E-post: Karina.Acevedo@ucsf.edu
-
Hovedetterforsker:
- Mathew Cooperberg, MD, MPH
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
Andre navn:
Data will be collected from participants medical charts which includes disease history, pathological findings, and other disease characteristics.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Identification of not yet identified factors contributing to prostate cancer
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Matthew Cooperberg, MD, University of California, San Francisco
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Prostatiske neoplasmer
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Datainnsamling
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Undersøkelser og spørreskjemaer
Andre studie-ID-numre
- 255517
- U54CA302452 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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