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Fecal Immunochemical Testing performed at yearly intervals.

Fecal Immunochemical Testing yearly, beginning at year 6.

Fecal Immunochemical Testing is a stool test specific for human hemoglobin.

Fecal Immunochemical Testing

Debra W Norwood

Wendy L Hobbs

Erica Habersham

Kyeshia Robinson

Daniel Murphy, MD

Daniel Murphy, M.D.

The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.

This study will evaluate the benefit of augmenting a compliant College of Gastroenterology colorectal cancer screening program with the addition of yearly FIT testing at two critical points in the current recommended follow up: 1. In patients found to have adenomatous polyps for the first time after colonoscopy, the addition of FIT in yearly intervals following index colonoscopy and 2. For subjects with "clean" colonoscopies (no polyps found), the addition of FIT at yearly intervals starting in year 6 and continuing to year 10 or subsequent colonoscopy. Current screening guidelines do not recommend the combination of colonoscopy and FOBT.

Two factors plague an effective colon cancer screening program: 1) a less than 100% sensitivity (95% ) for optical colonoscopy to detect colon cancer, and 2) Limitations of guaiac based stool testing: low sensitivity ( 5% in single use) for detection of colon cancer and the traditional gFOBT is cumbersome for patients to perform, impeding patient acceptance and adherence.

FIT offers a FOBT with improved sensitivity (65% for invasive colon cancer) and improved specificity and better patient compliance. The addition of FIT after initial colonoscopy could be applied to a screening program and thereby salvage "missed" lesions by increased detection rates

Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

Forsyth Medical Center

Rectal Diseases

All participants will be educated, on a simplified clinical and medical background of CRC; causes and risk factors for CRC; eligibility criteria for screening; lifestyle modifications to lower risk of developing CRC; screening methods for CRC, including FIT and colonoscopy; addressing myths and misconceptions about CRC; and information about resources for low-cost and no-cost screening, screening for the uninsured and screening for those without legal immigration documentation. Participants will also be educated on elements of fecal immunochemical testing (detects signs of cancer in the stool, can be done at home and sent to a laboratory for analysis, needs to be done yearly to ensure maximal effectiveness for cancer screening). Follow-up Assessment at 8 months complete follow-up form and assist in completion of peer outreach tracker Provide reminders to encourage participants to encourage peers to get FIT tested.

Provide CRC education, SN education, handouts and text message/social media posts example library. Monthly Telephone Support Provide any additional support to index participants for peer FIT testing, assist in completion of peer outreach tracker. Biweekly Text Messages. Follow-up Assessment (month 8 after intervention) Complete follow-up form and assist in completion of peer outreach tracker Provide reminders to encourage participants to encourage peers to get FIT tested.

FITx3 intervention and CRC education

Colorectal Cancer (CRC) education alone

Francesca Gany, MD, MS

Jennifer Leng, MD, MPH

Fransecsa Gany, MD, MS

Franscesca Gany, MD, MS

The Black community has higher rates of colorectal cancer and lower rates of colorectal cancer screenings than whites. Getting screened through FIT testing may help catch colorectal cancer earlier, when it is easier to treat. MSK has created a program to help people who have been FIT tested to also help their peers (family, friends, and colleagues) in their community get FIT tested. The researchers think that training people on peer outreach, such as telling people in your social network about FIT testing and how to get it, may increase the rate of colorectal cancer screening. The purpose of this study is to see if training people on peer outreach increases the number of people who get screened for colorectal cancer through FIT testing.

A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer

FITx3 RCT: A Pilot Randomized Controlled Trial Leveraging Social Networks to Encourage Three Peers to Complete Fecal Immunochemical Testing for Colorectal Cancer

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

CANCER PREVENTION FUND

Memorial Sloan Kettering Cancer Center

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stool specimens will be collected from participants before having a colonoscopy.

If the participant's colon has a healthy colon without any cancerous lesion, the stool specimen will be included in the healthy group.

Stool specimens will be collected from participants before having a colonoscopy.

If the participant's colon has precancerous lesion, such as adenoma, the stool specimen will be included in the disease group.

Also, specimens from confirmed colorectal cancer patients are included in the disease group.

Stool specimens are collected from participants in the outpatient department or the inpatient department. Both FIT and stool DNA real-time PCR are performed simultaneously. To improve the sensitivity and specificity of the colorectal cancer screening, this study enrolls multiple candidate genes to distinguish whether the participant has a high risk of colorectal cancer.

Stool DNA methylation detection

Yi-Chiao Cheng, MD

Yi-Chiao Cheng

This is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT).

This study recruits at least 80 participants, including 40 people of healthy controls, 20 people with adenoma, and 20 people with CRC, which were confirmed by colonoscopy. All fecal specimens from participants will be examined by FIT and multi-methylated target gene detection through real-time quantitative methylation-specific PCR (qMSP).

The objective of this study is to evaluate the sensitivity and specificity of multi-methylated target PCR compared with the FIT and confirm the examination results through colonoscopy.

The incidence rate and the mortality rate of colorectal cancer (CRC) have been steadily increasing worldwide. Early detection of CRC can provide great opportunities to help patients, increasing their 5-year survival rate. Colonoscopy has been considered as the golden standard of CRC screening method, but the invasive procedures cannot be widely adapted by recipients.

Nowadays, the most common CRC screening method is fecal immunochemical test (FIT) which is a cost-effective and non-invasive approach. The sensitivity of FIT for CRC detection is about 80%, but only 20% for adenoma.

The methylation level of candidate genes are determined by qMSP to estimate the risk of colorectal cancer. This study implements fecal DNA methylation test and fecal immunochemical test simultaneously to evaluate whether the fecal DNA methylation test can improve the detection rate of adenoma and CRC.

At least 40 specimens from participants with healthy colon at least 40 specimens from participants with adenoma/colorectal cancer

Fecal DNA Methylation Test for Colorectal Cancer Screening

A Fecal DNA Methylation Test for Colorectal Cancer Screening Using Multitarget Real-Time PCR Method-A Observational, Prospective Study

In this study, we estimate the sensitivity and specificity of methylation biomarker isolated from participant's stool DNA and perform FIT simultaneously.

The Ct values of candidate genes and GAPDH (reference gene) are determined by real-time PCR. The delta Ct values are calculated by Ct value of candidate gene - Ct value of GAPDH. Furthermore, the cut-off value of each candidate gene was determined based on the Receiver Operating Characteristic curve.

If the value of Fecal immunochemical test is more than 100 ng Hb/ml, the stool is considered as positive with fecal occult blood.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing	NCT00892593	Colon Cancer	Fecal Immunoche... Fecal Immunoche...	18 Years -	Forsyth Medical Center
A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer	NCT05793593	Colon Cancer Sc...	FITx3 intervent... Colorectal Canc...	45 Years - 75 Years	Memorial Sloan Kettering Cancer Center
Fecal DNA Methylation Test for Colorectal Cancer Screening	NCT04823793	Colorectal Canc... Colorectal Aden...	Stool DNA methy...	40 Years - 79 Years	Tri-Service General Hospital
A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer	NCT05793593	Colon Cancer Sc...	FITx3 intervent... Colorectal Canc...	45 Years - 75 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for fecal immunochemical testing