- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00706121
S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
Arizona
-
Tucson, Arizona, Vereinigte Staaten, 86724
- Arizona Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
|
400 IU daily by mouth for 7 - 12 years
Andere Namen:
1 pill by mouth daily for 7 - 12 years
Andere Namen:
|
Experimental: Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
|
200 mcg daily for 7 - 12 years
Andere Namen:
1 pill by mouth daily for 7 - 12 years
Andere Namen:
|
Experimental: Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
|
400 IU daily by mouth for 7 - 12 years
Andere Namen:
200 mcg daily for 7 - 12 years
Andere Namen:
|
Placebo-Komparator: Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
|
1 pill by mouth daily for 7 - 12 years
Andere Namen:
1 pill by mouth daily for 7 - 12 years
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From 1 year post randomization through study completion
|
From 1 year post randomization through study completion
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
Zeitfenster: From 1 year post randomization through study completion
|
From 1 year post randomization through study completion
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From 1 year post randomization through study completion
|
From 1 year post randomization through study completion
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CDR0000593329
- U10CA037429 (US NIH Stipendium/Vertrag)
- S0000D (Andere Kennung: SWOG)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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