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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Leisa Sutton, MAS
- Номер телефона: 858-822-6582
- Электронная почта: lsutton@health.ucsd.edu
Учебное резервное копирование контактов
- Имя: Samir Gupta, MD, MSCS, AGAF
- Номер телефона: 858-822-4499
- Электронная почта: s1gupta@ucsd.edu
Места учебы
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California
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La Jolla, California, Соединенные Штаты, 92037
- Moores Cancer Center, University of California, San Diego
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Enrollment rate
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Advanced neoplasia
Временное ограничение: 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.
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Sensitivity for advanced neoplasia
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Samir Gupta, MD, MSCS, AGAF, University of California, San Diego
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Новообразования по локализации
- Новообразования
- Кишечные заболевания
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Новообразования кишечника
- Заболевания прямой кишки
- Заболевания толстой кишки
- Патологические состояния, признаки и симптомы
- Колоректальные новообразования
- Болезнь
Другие идентификационные номера исследования
- 814209
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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