Clinical trial NCT02792023: Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)
Official title: Usefulness of Fecal Immunochemical Test in the Diagnosis Algorithm of Iron Deficiency Anemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Immunochemical occult blood test
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective study to test whether the immunochemical fecal occult blood test (FIT) for colorectal cancer (CRC) helps to prioritize patients with iron deficiency anemia for colonoscopy.

Detailed description: This is a multicenter (two centers), prospective study to test the accuracy of FIT for CRC detection in patients with severe IDA and its potential value for prioritizing colonoscopy.

An appointment with a gastroenterologist will be scheduled for patients with IDA referred for upper gastrointestinal endoscopy or colonoscopy. The gastroenterologist will check the inclusion and exclusion criteria. Eligible patients will sign the informed consent to carry out the following procedures:

1. Blood analysis to rule out celiac disease (anti-transglutaminase IgA antibodies and IgA).
2. A quantitative fecal immunological test (FIT: OC-Sensor ®) will be provided.
3. An appointment for colonoscopy and gastroscopy will be provided after completion of the FIT in all patients. During gastroscopy, duodenal biopsies from the second portion of the duodenum and duodenal bulb will be taken to rule out celiac disease. Biopsies from the stomach will be also taken to assess helicobacter pylori infection.
4. In patients with severe anemia colonoscopy and upper endoscopy will be prioritized (\<20 days) (primary outcome).
5. Patients with colonoscopy and gastroscopy without significant lesions, will be scheduled for the performance of a capsule endoscopy.
6. Endoscopists will be blind for the FIT results.
7. the following information will be collected: consumption of acetylsalicylic acid, non steroidal anti inflammatory drugs, oral anticoagulants, corticosteroids and proton pump inhibitors (PPI). In the case of patients receiving treatment with PPIs, they will be removed 15 days before the completion of the FIT and not resumed until the performance of the upper endoscopy.

The hypothesis of the study is that one-time FIT is a useful tool for increasing the efficiency of colonoscopy and can be used to prioritize outpatient colonoscopy in patients with IDA. In order to calculate the sample size required for the study, the investigators have assumed that FIT is positive in 25% of cases with iron deficiency anemia and 20% of them would have an advanced colorectal neoplasia at colonoscopy whereas only 10% of advanced colorectal neoplasias would be found in the remaining 75% patients with a negative FIT. Considering a type I error (alpha) of 5%, a power of 80% and a percentage of losses of 15%, 550 patients will be necessary to include. The investigators estimate that approximately 15% of these patients (n=83) will have severe anemia.

Eligibility criteria: Inclusion Criteria:

* Consecutive outpatients with iron deficiency anemia (Hemoglobin \< 13 g/dl in males and 12 g/dl in females) referred for upper endoscopy and/or colonoscopy.
* To sign the informed consent.

Exclusion Criteria:

* \< 18 years
* Pregnancy
* Personal history of inflammatory bowel disease
* Gastric / duodenal ulcer or gastrointestinal neoplasia
* Family history of hereditary CRC (Lynch Syndrome or familial adenomatous polyposis)
* Rectal bleeding / hematochezia
* Gastroscopy / colonoscopy / endoscopy capsule in the previous 5 years
* Patients not candidates for endoscopic studies because a low performance status
* Previous abdominal surgery
* Refusal to participate.

Primary outcomes:
measure: The number of patients with colorectal cancer among those with a positive immunochemical fecal test (Positive predictive value)
timeFrame: one year
Secondary outcomes:
measure: The number of patients with a significant lesion among those with a positive immunochemical fecal test (Positive predictive value) after the colonoscopy and after the upper endoscopy
timeFrame: one year
measure: The number of patients without a significant lesion among those with a negative immunochemical fecal test (negative predictive value) after the colonoscopy and after the upper endoscopy
timeFrame: one year
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Digestive Service, Huc
state: S/C DE Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Enrique Quintero, MD, PhD
role: STUDY_DIRECTOR
References:
citation: James MW, Chen CM, Goddard WP, Scott BB, Goddard AF. Risk factors for gastrointestinal malignancy in patients with iron-deficiency anaemia. Eur J Gastroenterol Hepatol. 2005 Nov;17(11):1197-203. doi: 10.1097/00042737-200511000-00008.
citation: Hamilton W, Lancashire R, Sharp D, Peters TJ, Cheng KK, Marshall T. The importance of anaemia in diagnosing colorectal cancer: a case-control study using electronic primary care records. Br J Cancer. 2008 Jan 29;98(2):323-7. doi: 10.1038/sj.bjc.6604165. Epub 2008 Jan 22.
citation: Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.
citation: Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
citation: Rodriguez-Alonso L, Rodriguez-Moranta F, Ruiz-Cerulla A, Lobaton T, Arajol C, Binefa G, Moreno V, Guardiola J. An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test. Dig Liver Dis. 2015 Sep;47(9):797-804. doi: 10.1016/j.dld.2015.05.004. Epub 2015 May 15.
citation: Cubiella J, Salve M, Diaz-Ondina M, Vega P, Alves MT, Iglesias F, Sanchez E, Macia P, Blanco I, Bujanda L, Fernandez-Seara J. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. Colorectal Dis. 2014 Aug;16(8):O273-82. doi: 10.1111/codi.12569.