Clinical trial NCT05514561: FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms
Official title: Diagnostic Performance of Fecal Immunochemical Test and Fecal Calprotectin in Detection of Ileocolonic Lesions in Patients With Chronic Lower Gastrointestinal Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Adenoma
Colitis
Keywords: Fecal immunochemical test
calprotectin
Colorectal neoplasm
Colorectal cancer
Colitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enrolled adults older than 18 years with chronic lower GI symptoms for more than 1 month and were scheduled for a colonoscopy. The lower GI symptoms consisted of any of the followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, and abdominal bloating. The stool samples were collected one to two days before the bowel preparation. All patients provided written informed consent. Patients who did not return their stool samples and whose complete colonoscopy was not achieved were excluded.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The diagnostic performance of fecal calprotectin in diagnosis of significant ileocolonic lesions
timeFrame: 1 month
Secondary outcomes:
measure: The diagnostic performance of fecal immunochemical test in diagnosis of significant ileocolonic lesions
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
name: Julajak Limsrivilai, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: