Colorectal Neoplasia Screening w Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Ctrs: The CONCeRN Trial
16 juli 2020 bijgewerkt door: National Cancer Institute (NCI)
Diet, Other Risk Factors, Genetics and the Risk of Colorectal Neoplasia in a Screening Trial of Asymptomatic Women: A Sub-Study of the CONCeRN Trial
The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening.
The primary purpose of the main study is to determine the extent to which advanced neoplastic lesions will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a screening procedure and to resolve current debate about the significance of sigmoidoscopic detection of single, small, tubular adenomas (i.e., do they imply greater risk for large adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope, or is there no increased risk?).
Women enrolled in the trial receive colonoscopy during which all identified polyps are removed and also during which two pinch biopsies of apparently-normal tissue are taken.
In addition, before the colonoscopy is performed, patients wil have blood drawn and answer a brief questionnaire on risk factors for colorectal cancer.
The sub-study proposes to add on a more extensive questionnaire to assess dietary and other lifesyle factors potentially related to colorectal cancer, and to draw additional blood for assessment of nutritional status and for analysis of genetic polymorphisms related to colorectal cancer.
With the additional information available from these questionnaires and blood samples, it will be possible to explore the extent to which various dietary and genetic risk factors are related to colorectal polyps in asymptomatic women of average risk for disease.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening.
The primary purpose of the main study is to determine the extent to which advanced neoplastic lesions will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a screening procedure and to resolve current debate about the significance of sigmoidoscopic detection of single, small, tubular adenomas (i.e., do they imply greater risk for large adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope, or is there no increased risk?).
Women enrolled in the trial receive colonoscopy during which all identified polyps are removed and also during which two pinch biopsies of apparently-normal tissue are taken.
In addition, before the colonoscopy is performed, patients will have blood drawn and answer a brief questionnaire on risk factors for colorectal cancer.
The NCI-led sub-study added a more extensive questionnaire to assess dietary and other lifestyle factors potentially related to colorectal cancer, and obtained additional blood for assessment of nutritional status and for analysis of genetic polymorphisms related to colorectal cancer.
With the additional information available from these questionnaires and blood samples, it will be possible to explore the extent to which various dietary and genetic risk factors are related to colorectal polyps in asymptomatic women of average risk for disease.
Recruitment is now complete at all sites.
A total of 937 women were recruited.
Of these, about one-quarter of the women with one or more adenomas had an advanced adenoma, defined as being greater than or equal to 1 cm in diameter, or having high grade dysplasia or villous elements).
These neoplasia prevalence figures are in line with initial projections.
Active contact with participants is concluded.
We have now entered into a data analysis phase.
Studietype
Observationeel
Inschrijving (Werkelijk)
937
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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San Diego, California, Verenigde Staten, 92134-5000
- Naval Medical Center, San Diego
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20889
- National Naval Medical Center
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Virginia
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Portsmouth, Virginia, Verenigde Staten, 23708
- Naval Medical Center, Portsmouth
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar tot 79 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening@@@
Beschrijving
- INCLUSION CRITERIA:
50-79, asymptomatic women of average risk referred for colorectal screening.
40-79 year-old asymptomatic women referred for colorectal screening with a history of colorectal cancer in a first degree relative.
EXCLUSION CRITERIA:
History of positive stool guiaic within six months of referral.
History of iron deficiency anemia within six months of referral (Note: if patients have not had stool guiacs, complete blood cell count or ferritin performed within the last six months, then these tests will be performed at time of study enrollment).
History of normal colonoscopy or barium enema within past ten years or history of normal flexible sigmoidoscopy within past 5 years.
History of adenomatous polyps, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis.
History of rectal bleeding or hematochezia within the past 12 months.
Unintentional weight loss greater than 10 pounds within previous six months.
Pregnant women.
Subjects under 18 years of age.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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1
Asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rashmi Sinha, Ph.D., National Cancer Institute (NCI)
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Adamson RH, Thorgeirsson UP, Snyderwine EG, Thorgeirsson SS, Reeves J, Dalgard DW, Takayama S, Sugimura T. Carcinogenicity of 2-amino-3-methylimidazo[4,5-f]quinoline in nonhuman primates: induction of tumors in three macaques. Jpn J Cancer Res. 1990 Jan;81(1):10-4. doi: 10.1111/j.1349-7006.1990.tb02500.x.
- Bosron WF, Li TK. Genetic polymorphism of human liver alcohol and aldehyde dehydrogenases, and their relationship to alcohol metabolism and alcoholism. Hepatology. 1986 May-Jun;6(3):502-10. doi: 10.1002/hep.1840060330.
- Boutron MC, Faivre J, Marteau P, Couillault C, Senesse P, Quipourt V. Calcium, phosphorus, vitamin D, dairy products and colorectal carcinogenesis: a French case--control study. Br J Cancer. 1996 Jul;74(1):145-51. doi: 10.1038/bjc.1996.330.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 februari 2000
Primaire voltooiing (Werkelijk)
16 juli 2020
Studie voltooiing (Werkelijk)
16 juli 2020
Studieregistratiedata
Eerst ingediend
19 juni 2006
Eerst ingediend dat voldeed aan de QC-criteria
19 juni 2006
Eerst geplaatst (Schatting)
21 juni 2006
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juli 2020
Laatste update ingediend die voldeed aan QC-criteria
16 juli 2020
Laatst geverifieerd
1 juli 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 999900010
- OH00-C-N010
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