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To Explore Racial Differences in Potential Risk Factors for Developing Prostate Cancer in the VA Population.

16 oktober 2008 uppdaterad av: US Department of Veterans Affairs

Prostate Cancer Case-Control Study: Black Versus White: VA Versus Private Sector

Primary Objectives: To explore racial differences in potential risk factors for developing prostate cancer in the VA population and to compare and contrast the results of this study with that of an ongoing NCI-funded study in North Carolina.

Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and whites. To determine whether screening behavior differs in men diagnosed with early stage prostate cancer versus those with later stage disease as well as to determine if screening behavior differences exist between blacks and whites.

Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and behaviors about prostate cancer; and 4) treatment choices.

Intervention: N/A

Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among African Americans the incidence and mortality from prostate cancer is even greater. Although incidence rates in the Southern United States tend to be only slightly higher than that of the nation, a clear discrepancy exists between national mortality rates and those in the Southeastern United States. Notably high rates, particularly among African Americans are observed and in North Carolina the prostate cancer mortality rate among African Americans is the highest of any state in the nation. In spite of these statistics, very little is known about racially based differences in the etiology of this disease.

This study hypothesizes that racial differences in the incidence and mortality of prostate cancer may be a result of multiple factors including those that are socioeconomic, environmental, dietary and genetic. This research will provide insight into gene-environmental interactions that initiate and promote prostatic neoplasia as well as address whether there are differences in patterns of care which impact morbidity and survival. The results of this study will also be compared to findings in non-veterans that are being generated through an NCI-funded sister study of these issues under the direction of co-investigator, Dr. JoEllen Schildkraut of Duke University.

Subjects were identified from pathology reports extracted from VISTA. Additionally, subjects were identified by reviewing radiation/oncology clinic records for those subjects referred for radiation treatment. Subject enrollment concluded with 100 cases and 98 controls enrolled in the study

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Primary Objectives: To explore racial differences in potential risk factors for developing prostate cancer in the VA population and to compare and contrast the results of this study with that of an ongoing NCI-funded study in North Carolina.

Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and whites. To determine whether screening behavior differs in men diagnosed with early stage prostate cancer versus those with later stage disease as well as to determine if screening behavior differences exist between blacks and whites.

Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and behaviors about prostate cancer; and 4) treatment choices.

Intervention: N/A

Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among African Americans the incidence and mortality from prostate cancer is even greater. Although incidence rates in the Southern United States tend to be only slightly higher than that of the nation, a clear discrepancy exists between national mortality rates and those in the Southeastern United States. Notably high rates, particularly among African Americans are observed and in North Carolina the prostate cancer mortality rate among African Americans is the highest of any state in the nation. In spite of these statistics, very little is known about racially based differences in the etiology of this disease.

This study hypothesizes that racial differences in the incidence and mortality of prostate cancer may be a result of multiple factors including those that are socioeconomic, environmental, dietary and genetic. This research will provide insight into gene-environmental interactions that initiate and promote prostatic neoplasia as well as address whether there are differences in patterns of care which impact morbidity and survival. The results of this study will also be compared to findings in non-veterans that are being generated through an NCI-funded sister study of these issues under the direction of co-investigator, Dr. JoEllen Schildkraut of Duke University.

Subjects are identified from pathology reports extracted from VISTA. It has been determined that pathology reports alone are not a sufficient source of identifying cases because not all patients coming to VA for treatment have diagnostic pathology completed at the Durham VA. Therefore, we have added additional protocols for subject identification such as reviewing radiation/oncology clinic records for those subjects referred for radiation treatment. To-date, 78 cases and 66 controls have been enrolled in the study. To increase accrual rates, in-home visits have been used when necessary, and the Richmond, VA and Asheville, NC VAMCs have been added as participating study sites. Due to patient accrual problems and project staffing changes, the Durham ERIC has granted this study a six-month, no-cost extension through 7/31/2001.

Studietyp

Observationell

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • VA Medical Center, Durham

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 74 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

Veterans with Prostate Cancer

Exclusion Criteria:

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Kohorter och interventioner

Grupp / Kohort
1

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Philip Walther, VA Medical Center, Durham

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 1998

Primärt slutförande

7 december 2022

Avslutad studie

7 december 2022

Studieregistreringsdatum

Först inskickad

29 december 2000

Först inskickad som uppfyllde QC-kriterierna

30 december 2000

Första postat (Uppskatta)

1 januari 2001

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 oktober 2008

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 oktober 2008

Senast verifierad

1 februari 2003

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

3
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