Colorectal Neoplasia Screening w Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Ctrs: The CONCeRN Trial
2020年7月16日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
観察的
入学 (実際)
937
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92134-5000
- Naval Medical Center, San Diego
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Maryland
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Bethesda、Maryland、アメリカ、20889
- National Naval Medical Center
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Virginia
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Portsmouth、Virginia、アメリカ、23708
- Naval Medical Center, Portsmouth
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～79年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
Asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening@@@
説明
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Rashmi Sinha, Ph.D.、National Cancer Institute (NCI)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2000年2月14日
一次修了 (実際)
2020年7月16日
研究の完了 (実際)
2020年7月16日
試験登録日
最初に提出
2006年6月19日
QC基準を満たした最初の提出物
2006年6月19日
最初の投稿 (見積もり)
2006年6月21日
学習記録の更新
投稿された最後の更新 (実際)
2020年7月17日
QC基準を満たした最後の更新が送信されました
2020年7月16日
最終確認日
2020年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。