The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
調査の概要
詳細な説明
If you agree to take part in this study, you will have a single sample (8-10 teaspoons) of blood collected, depending upon current health status. The blood will be drawn at MD Anderson. If you cannot come to the clinic, a blood drawing kit will be sent to the your home, which will include instructions and a postage-paid return express mail envelope. Phlebotomy charges connected to this study will be paid by the study. The blood sample will be sent to a research laboratory at MD Anderson for analyses. If you are unwilling or unable to give a blood sample, you can give a saliva sample instead. In this case, a kit will be mailed to you with instructions for obtaining the saliva sample. A prepaid envelope will be included for its return. Participants who previously participated in Protocol PA11-0567 and provided a blood sample do not need to provide another blood sample. The previously stored blood sample collected by Protocol PA11-0567 may be used.
You will be asked to answer a series of questions. These questions will ask about foods eaten either one year ago or one year before the first diagnosis of cancer. There will also be questions about cooking methods as well as overall health, and vitamin and medication use. Some of the questions are personal, but all answers will be kept strictly private.
The questionnaire will be sent to your home via U.S. or express mail. It may take several hours to complete the survey, but there is no time limit on its completion. There are no right or wrong answers to the questions. A postage-paid return envelope will be provided for the return of the questionnaire.
Solid tumor material and colonoscopy specimens of normal tissue will be collected from participants requiring either colonoscopy or surgery for routine clinical reasons. The tumor fragments will be collected from specimens. Tissue required for a clinical pathology diagnosis will not be used for research purposes.
This is an investigational study. About 2,000 patients and family members will take part in this study. All will be enrolled at MD Anderson.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
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
Inclusion Criteria:
- All patients with a new referral for a diagnosis of colorectal cancer (adenocarcinoma) and/or HNPCC-related cancers at the UTMDACC will be considered potentially eligible for this study regardless of prior treatment.
- Families maintained at the UTMDACC Hereditary Colon Cancer Registry that have a known germline mutation in a mismatch repair gene or contain two or more first degree relatives diagnosed with CRC and/or any HNPCC-related cancers, one of whom must be less than or equal to 50 years at diagnosis.
- First-degree and more distant relatives of individuals diagnosed with CRC and/or any HNPCC-related cancers from either of the groups in 1 and 2 (above).
- Any patient diagnosed with CRC and/or any HNPCC-related cancers less than or equal to 45 years of age.
- Greater than or equal to age 18 at time of study.
- Able to provide informed consent to participate in this study indicating that they are aware of the investigational nature, in keeping with the policies of this hospital.
- Non-HNPCC quartets, defined as parents and two offspring who do not carry a mismatch repair gene mutation. These non-HNPCC quartets should have no personal history of cancer, nor cancer in any first degree relatives of the quartet members, nor history of trinucleotide repeat syndromes. Non-HNPCC parents in a quartet should be less than 34 years old at the time the offspring were born.
- Lynch Syndrome patients identified and recruited through Protocol PA11-0567 who opt into Optional Procedure B, which consents the patient to participate in this study.
Exclusion Criteria:
- Diagnosis of current major psychiatric disorder, per DSM-III-R (or DSM IV).
- Age less than 18 years at time of enrollment.
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 |
|---|---|
|
Gene Mutation
Group with increased risk for developing colorectal and/or other cancers as the result of an inherited gene mutation, family history of cancer, or an early age of cancer onset.
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Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete.
他の名前：
|
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No Cancer History
Group with little/no personal or family history of cancer.
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Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete.
他の名前：
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Spouses
Spouses of those who may have an increased risk for developing colorectal and/or other cancers as the result of an inherited gene mutation, family history of cancer, or an early age of cancer onset, or little/no personal or family history of cancer.
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Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete.
他の名前：
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to Onset for Colorectal Cancer
時間枠：Overall study period up to 15 years.
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Primary endpoint is time to onset for colorectal cancer using Cox proportional hazard regression for determining the role that polymorphic variants of genes have on risk for development of HNPCC at an early age.
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Overall study period up to 15 years.
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- DM94-060
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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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