FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms

Colorectal Cancer Clinical Trial

Official title:

Diagnostic Performance of Fecal Immunochemical Test and Fecal Calprotectin in Detection of Ileocolonic Lesions in Patients With Chronic Lower Gastrointestinal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05514561
• Other study ID #: Si238/2020
• Status: Completed
• Start date: March 22, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic lower gastrointestinal (GI) symptoms, including lower abdominal pain, bowel habit change, bleeding per rectum, and abdominal bloating, are caused by functional gastrointestinal disorders (FGID) and organic intestinal disorders, including colorectal cancer and chronic colitis. The presence of alarming features, such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer, indicates organic diseases, and colonoscopy should be required. However, using only alarming features may not be sufficiently accurate. For example, anemia or significant weight loss, which are highly specific for organic disorders, usually occur in late-stage diseases. Conversely, the parameters with high sensitivity, such as the age of onset after 50 years, have a low specificity; colonoscopy in these patients may not be urgent. Therefore, tests that can help discriminate organic from functional diseases are warranted. Immunochemical fecal occult blood tests (iFOBT) and fecal calprotectin (FC) are biomarkers that indicate organic lesions in the gastrointestinal tract and could help diagnose patients with lower GI symptoms more accurately.

Description:

This study was a single-center, prospective cohort study undertaken at Siriraj hospital between March 2020 to November 2022. Eligible participants were required to collect their stool samples one to two days before the bowel preparation. The stool was sent for fresh smear examination, quantitative FIT (OC-SENSOR, EIKEN CHEMICAL, Japan), and quantitative fecal calprotectin (EliA Calprotectin 2, Phadia, Sweden). Blood samples were obtained on the day of the colonoscopy and were tested for complete blood count, albumin, and C-reactive protein (CRP) levels. In addition, clinical information was obtained, including alarm features such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer. Colonoscopic findings and histopathological findings were used as the reference standard for diagnosis. We analyzed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and colitis, of each diagnostic modality comparing to the reference standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1007
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• age of at least 18 years

• patients with at least one month of any lower gastrointestinal symptoms are as followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, abdominal bloating,

• patients who are scheduled for a colonoscopy

Exclusion criteria

• incomplete colonoscopy

• incomplete stool collection

Related Conditions & MeSH terms

• Adenoma
• Colitis
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Fecal calprotectin
To calculate the diagnostic accuracy of fecal calprotectin in the diagnosis of significant ileocolonic lesions
• Fecal immunochemical test
To calculate the diagnostic accuracy of the fecal immunochemical test in the diagnosis of significant ileocolonic lesions

Locations

Country	Name	City	State
Thailand	Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic performance of fecal calprotectin in diagnosis of significant ileocolonic lesions	The sensitivity, specificity, and accuracy of fecal calprotectin in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis	1 month
Secondary	The diagnostic performance of fecal immunochemical test in diagnosis of significant ileocolonic lesions	The sensitivity, specificity, and accuracy of fecal immunochemical test in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis	1 month