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NCT05514561
FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms
trial testing Fecal calprotectin in Colorectal Cancer in 1,007 participants. Completed in 1 November 2022.
1 November 2022
Quick facts
| Lead sponsor | Mahidol University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,007 |
| Start date | 22 March 2020 |
| Primary completion | 1 November 2022 |
| Estimated completion | 1 November 2022 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Fecal calprotectin
- Fecal immunochemical test
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Colorectal Adenoma — all drugs for Colorectal Adenoma →
- Colitis — all drugs for Colitis →
Sponsor
Mahidol University
Who can join
18 and older, any sex, with Colorectal Cancer or Colorectal Adenoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluating the Efficacy of Fecal Immunochemical Test, Fecal Calprotectin, and Serum C-Reactive Protein in Diagnosing Patients With Chronic Lower Gastrointestinal Symptoms.
Limsrivilai J, Yodmalai C, Chaemsupaphan T, Sattayalertyanyong O, et al · · 2024 · cited 1× · PMID 38994833 · DOI 10.14309/ctg.0000000000000747
Verify or expand the search:
- PubMed search for NCT05514561
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal calprotectin
Trials testing the same drug.
- NCT03808506 — Relationship Between Baseline Burden of Disease and TDM in Ulcerative Colitis · withdrawn
- NCT04491799 — Fecal Calprotectin Level in Patients With Nosocomial Diarrhea · completed
- NCT03633669 — Effect of Real-world Tight Control Management of Inflammatory Bowel Disease · NA · withdrawn
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
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- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Other Mahidol University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05514561 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mahidol University
- Last refreshed: 14 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05514561.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing