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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Leisa Sutton, MAS
- Número de telefone: 858-822-6582
- E-mail: lsutton@health.ucsd.edu
Estude backup de contato
- Nome: Samir Gupta, MD, MSCS, AGAF
- Número de telefone: 858-822-4499
- E-mail: s1gupta@ucsd.edu
Locais de estudo
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California
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La Jolla, California, Estados Unidos, 92037
- Moores Cancer Center, University of California, San Diego
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Enrollment rate
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Advanced neoplasia
Prazo: 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
Prazo: 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.
|
|
Specificity for advanced neoplasia
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Samir Gupta, MD, MSCS, AGAF, University of California, San Diego
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças do cólon
- Condições Patológicas, Sinais e Sintomas
- Neoplasias Colorretais
- Doença
Outros números de identificação do estudo
- 814209
Plano para dados de participantes individuais (IPD)
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