Genetic Study of Patients and Families With a History of Colorectal Cancer
The Familial Colorectal Neoplasia Collaborative Group
RATIONALE: Determination of genetic markers for colorectal cancer may help doctors to identify patients who are at risk.
PURPOSE: Genetic testing study of patients and families with a history of colorectal cancer to identify patients who are at risk of developing colorectal cancer.
調査の概要
詳細な説明
OBJECTIVES: I. Select patients with colon cancer and families at high-risk for colon cancer and collect leukocyte DNA, immortalized cell lines, plasma, and tumor specimens from these individuals and from control individuals. II. Develop patient education, counseling, and follow up plans for these individuals. III. Compare the frequency of defective DNA mismatch repair in individuals with familial colon cancer versus all colon cancers by using antibodies to the hMSH2 and hMLH1 protein products.
OUTLINE: This is a multicenter study. Patients, family members, and control individuals complete an extended telephone interview, an extended personal interview, and an epidemiological survey, and contribute a blood specimen. Blood and tumor specimens are examined for the specific pattern of immunohistochemical expression of hMSH2 and HMLH1 to determine the frequency or lack of expression of these two protein products. Patients may be contacted periodically (about every 3 years) to update information about health, health practices, and family history. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
PROJECTED ACCRUAL: At least 500-600 families (approximately 1500 patients) and the same number of matched controls will be accrued for this study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Arizona
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Scottsdale、Arizona、アメリカ、85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Urbana、Illinois、アメリカ、61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids、Iowa、アメリカ、52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines、Iowa、アメリカ、50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City、Iowa、アメリカ、51101-1733
- Siouxland Hematology-Oncology
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Saint Cloud、Minnesota、アメリカ、56303
- CentraCare Clinic
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Nebraska
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Omaha、Nebraska、アメリカ、68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck、North Dakota、アメリカ、58501
- Medcenter One Health System
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South Dakota
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Rapid City、South Dakota、アメリカ、57709
- Rapid City Regional Hospital
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Sioux Falls、South Dakota、アメリカ、57104
- CCOP - Sioux Community Cancer Consortium
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Saskatchewan
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Regina、Saskatchewan、カナダ、S4T 7T1
- Allan Blair Cancer Centre
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
DISEASE CHARACTERISTICS: Primary colorectal cancer and participating in one of the following NCCTG protocols: NCCTG-784852: No Treatment Control Versus Levamisole Versus Levamisole Plus 5-Fluorouracil NCCTG-794604: No Treatment Control Versus 5-FU by Portal Vein Infusion NCCTG-794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU NCCTG-844652: An Intergroup Study - An Evaluation of Levamisole Alone or Levamisole Plus 5-Fluorouracil as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon NCCTG-864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controlled Evaluation of (A) Protracted-Infusion-5-Fluorouracil (5-FU) as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy NCCTG-874651: M/N - A Controlled Evaluation of Recombinant Interferon-Gamma (IFN-GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon NCCTG-894651: A Controlled Phase III Evaluation of 5-Fluorouracil with Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer NCCTG-914653: A Phase III Evaluation of High-Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer Adequate tissue for review OR Families of patients meeting the above criteria OR Colon cancer patient and population controls not in a high-risk family OR Spouse of a high-risk colon cancer patient
PATIENT CHARACTERISTICS: Age: Not specified Performance status: See Disease Characteristics Life expectancy: See Disease Characteristics Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics
PRIOR CONCURRENT THERAPY: See Disease Characteristics
研究計画
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 |
介入・治療 |
|---|---|
|
Group 1
Patients, family members, and control individuals complete an extended telephone interview, an extended personal interview, and an epidemiological survey, and contribute a blood specimen.
Blood and tumor specimens are examined for the specific pattern of immunohistochemical expression of hMSH2 and HMLH1 to determine the frequency or lack of expression of these two protein products.
Patients may be contacted periodically (about every 3 years) to update information about health, health practices, and family history.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
frequency of defective DNA mismatch repair in individuals with familial colon cancer versus all colon cancers by using antibodies to the hMSH2 and hMLH1 protein products
時間枠：Up to 5 years
|
Up to 5 years
|
協力者と研究者
捜査官
- スタディチェア：Noralane M. Lindor, MD、Mayo Clinic
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NCCTG-974655
- CDR0000066737 (レジストリ識別子：PDQ (Physician Data Query))
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。
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-
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