Symptomatic FIT for Colon Cancer Detection, a Pilot Study
This pilot study will assess whether a larger study of stool testing for colorectal cancer is practical. It plans to enroll 40 adults born in 1960 or later who have new symptoms that could be related to colorectal cancer. Participants will collect a stool sample at home using a fecal immunochemical test (FIT), complete a questionnaire, and undergo blood tests and colonoscopy as part of their usual medical care. Researchers will compare research FIT results with colonoscopy findings and assess recruitment, sample collection, and completion of study activities. Research FIT results will not routinely be shared with participants or their clinicians. If a research FIT result is abnormal and colonoscopy has not been completed within six months, the study team will notify the primary care provider to encourage colonoscopy follow-up.
調査の概要
状態
詳細な説明
This prospective pilot cohort study will evaluate the feasibility of implementing a symptomatic FIT research strategy in the UC San Diego Health system. Recruitment will use electronic health record screening and clinician and patient outreach. Consented participants will provide an at-home stool specimen for research FIT testing and questionnaire data. Usual-care complete blood count, ferritin, and colonoscopy findings will be collected. Feasibility assessments include recruitment, enrollment, stool specimen return, and completion of study activities. Preliminary FIT performance will be assessed against adequate-quality usual-care colonoscopy completed within six months of FIT.
A transition from UCSD laboratory FIT testing to quantitative research FIT testing performed by Polymedco is planned, conditional on IRB approval and execution of the required institutional agreement. Participants using the quantitative FIT kit will mail specimens directly to Polymedco. Specimens and results will be coded by study ID, and the linkage key will remain at UCSD without Polymedco access. The study is supported by a gift from Curebound.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Leisa Sutton, MAS
- 電話番号：858-822-6582
- メール：lsutton@health.ucsd.edu
研究連絡先のバックアップ
- 名前：Samir Gupta, MD, MSCS, AGAF
- 電話番号：858-822-4499
- メール：s1gupta@ucsd.edu
研究場所
-
-
California
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La Jolla、California、アメリカ、92037
- Moores Cancer Center, University of California, San Diego
-
-
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
UC San Diego Health primary care patients born in 1960 or later with newly identified signs or symptoms potentially consistent with colorectal cancer. Potential participants will be identified through electronic health record screening and clinician or patient outreach.
説明
Inclusion Criteria:
- Adults 18 years or older, born in 1960 or later.
- Newly reported signs or symptoms potentially consistent with colorectal cancer: hematochezia, persistent abdominal pain, altered bowel habits (constipation, diarrhea, or narrow stools), unintentional weight loss greater than 5 pounds, or iron deficiency anemia. Symptoms must not have been reported to the primary care provider before the index visit.
Exclusion Criteria:
- Acute symptoms within 14 days requiring urgent evaluation.
- Up-to-date colorectal cancer screening: colonoscopy within 10 years, sigmoidoscopy within 5 years, FIT within 1 year, or multitarget stool DNA/RNA or cell-free DNA testing within 3 years.
- Prior colorectal cancer, colorectal resection, hereditary colorectal cancer syndrome (including Lynch syndrome or familial adenomatous polyposis), or inflammatory bowel disease.
- Documented infectious cause that clinically explains the symptoms. A negative infectious workup or absence of an infectious workup does not exclude participation.
- Pregnancy.
- Lack of health insurance for usual-care procedures.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Adults with new colorectal cancer-related signs or symptoms
Adults 18 years or older, born in 1960 or later, with newly identified signs or symptoms potentially consistent with colorectal cancer. Participants provide an at-home stool specimen for research FIT testing and complete a questionnaire. Usual-care blood test and colonoscopy findings are collected for comparison. |
All enrolled subjects will complete a quantitative immunochemical test and reference colonoscopy |
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 |
|---|---|---|
|
Enrollment rate
時間枠：From recruitment opening through the end of recruitment, up to 12 months
|
Percentage of eligible patients approached who provide informed consent and enroll in the study. Calculated as the number enrolled divided by the number of eligible patients approached, multiplied by 100. |
From recruitment opening through the end of recruitment, up to 12 months
|
|
Stool sample return rate
時間枠：From enrollment through completion of participant follow-up, up to 6 months
|
Percentage of enrolled participants who return a stool specimen for research fecal immunochemical testing. Calculated as the number returning a specimen divided by the number enrolled, multiplied by 100. |
From enrollment through completion of participant follow-up, up to 6 months
|
|
Completion of study activities
時間枠：From enrollment through completion of participant follow-up, up to 6 months
|
Percentage of enrolled participants completing each planned activity: research stool specimen collection, study questionnaire, usual-care blood testing, and usual-care colonoscopy. Completion percentages will be reported separately for each activity, using all enrolled participants as the denominator. |
From enrollment through completion of participant follow-up, up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Advanced neoplasia
時間枠：At time of colonoscopy completed within 6 months of FIT.
|
Proportion of patients with advanced neoplasia (advanced adenoma, advanced serrated polyp, or colorectal cancer) at time of colonoscopy. |
At time of colonoscopy completed within 6 months of FIT.
|
|
Sensitivity for advanced neoplasia
時間枠：At time of colonoscopy completed within 6 months of FIT.
|
Proportion of people with advanced neoplasia who have an abnormal FIT (defined at a 4 nanogram/g feces cutoff) . Denominator = # of people with advanced neoplasia; Numerator = # of people with an abnormal FIT |
At time of colonoscopy completed within 6 months of FIT.
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|
Specificity for advanced neoplasia
時間枠：At time of colonoscopy completed within 6 months of FIT.
|
Proportion of people without advanced neoplasia who have normal FIT (defined at below a 4 nanogram/g feces cutoff) . Denominator = # of people without advanced neoplasia; Numerator = # of people with a normal FIT |
At time of colonoscopy completed within 6 months of FIT.
|
協力者と研究者
協力者
捜査官
- 主任研究者：Samir Gupta, MD, MSCS, AGAF、University of California, San Diego
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 814209
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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