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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA287257-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Columbia University | OTHER |
| University of Michigan | OTHER |
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The purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (FIT) in comparison to colonoscopy in patients with Lynch Syndrome (LS) who are undergoing colonoscopy surveillance.
Lynch syndrome (LS), the most common inherited cause of colorectal cancer (CRC) affecting about 1.2 million Americans. Colonoscopy starting early in adulthood and repeated yearly or biennially is the only recommended surveillance strategy which translates into about 25-50 lifetime colonoscopies. This intensive colonoscopy surveillance is not ideal because CRC risk varies widely by LS gene and age, colonoscopies are invasive, costly, and not readily accessible to all patients, and adherence is suboptimal.
This clinical study will examine the performance of the fecal immunochemical test (FIT) in Lynch Syndrome (LS) patients undergoing colonoscopy surveillance. In addition to assessing the characteristics of the FIT test, such as specificity, sensitivity, and both negative and positive predictive values, the study will also explore LS patients' attitudes toward and acceptability of non-invasive testing methods. This comprehensive approach aims to provide insights into both the diagnostic effectiveness of FIT and the potential for improving patient adherence to screening protocols through less invasive options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive surveillance test | Easily accessible, affordable and acceptable tests can be used to triage Lynch syndrome patients to colonoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal immunochemical test | Other | Detects blood in stool |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Measure of specificity | Measure specificity of Fecal immunochemical test (FIT) in Lynch Syndrome (LS) patients undergoing colonoscopy surveillance | baseline -12 months |
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Inclusion Criteria:
Exclusion Criteria:
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People aged 20 - 80 years who have been diagnosed with Lynch syndrome
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Kupfer, MD | Contact | (773) 834-1438 | skupfer@bsd.uchicago.edu | |
| Kristi Kearney, RN | Contact | 773-834-7414 | kkearney@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sonia Kupfer, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60639 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Blood, Urine, and stool samples will be collected
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Columbia University | Recruiting | New York | New York | 10032 | United States |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |