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S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP)

6. december 2019 opdateret af: Southwest Oncology Group

S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT

RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.

PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
  • To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
  • To assess the effect of selenium on colorectal cancer (CRC) incidence.

Secondary

  • To assess the effect of vitamin E on CRA occurrence.
  • To assess the effect of vitamin E on CRC incidence.

Tertiary

  • To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence.
  • To explore the effect modification of selenium and vitamin E by body mass index.

OUTLINE: This is a multicenter study.

Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer.

Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically.

Participants are followed annually.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

8094

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 86724
        • Arizona Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

DISEASE CHARACTERISTICS:

  • Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000
  • Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial

PATIENT CHARACTERISTICS:

  • Willing to sign an applicable medical records release form
  • Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
Medicin: Vitamin E
400 IU daily by mouth for 7 - 12 years
Andre navne:
  • alfa tocopherol
Medicin: selenium placebo
1 pill by mouth daily for 7 - 12 years
Andre navne:
  • placebo
Eksperimentel: Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
Medicin: Selenium
200 mcg daily for 7 - 12 years
Andre navne:
  • L-selenomethionin
Medicin: Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
Andre navne:
  • placebo
Eksperimentel: Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
Medicin: Vitamin E
400 IU daily by mouth for 7 - 12 years
Andre navne:
  • alfa tocopherol
Medicin: Selenium
200 mcg daily for 7 - 12 years
Andre navne:
  • L-selenomethionin
Placebo komparator: Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Medicin: selenium placebo
1 pill by mouth daily for 7 - 12 years
Andre navne:
  • placebo
Medicin: Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
Andre navne:
  • placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion
Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
Tidsramme: From 1 year post randomization through study completion
Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia
From 1 year post randomization through study completion
Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion
Effect of Selenium on Occurrences of Multiple (>2) Adenomas
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion

Sekundære resultatmål

Resultatmål
Tidsramme
Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion

Andre resultatmål

Resultatmål
Tidsramme
Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion
Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion
Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion
Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Tidsramme: From 1 year post randomization through study completion
From 1 year post randomization through study completion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2008

Primær færdiggørelse (Faktiske)

1. oktober 2015

Studieafslutning (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først indsendt

26. juni 2008

Først indsendt, der opfyldte QC-kriterier

26. juni 2008

Først opslået (Skøn)

27. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000593329
  • U10CA037429 (U.S. NIH-bevilling/kontrakt)
  • S0000D (Anden identifikator: SWOG)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

http://swog.org/Visitors/Download/Policies/Policy43.pdf

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med Vitamin E

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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