Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)

Colorectal Cancer Clinical Trial

— IDAFIT  

Official title:

Usefulness of Fecal Immunochemical Test in the Diagnosis Algorithm of Iron Deficiency Anemia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02792023
• Other study ID #: FIT-Iron deficiency anemia
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: October 2019

Study information

• Verified date: February 2019
• Source: Hospital Universitario de Canarias
• Contact: Marta Carrillo, MD, PhD
• Phone: 34-922678000
• Email: martacarry[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Immunochemical fecal occult blood test
Participants will be provided with a single immunochemical fecal occult blood test. Participants will introduce a small sample of feces inside and bring the test to the hospital

Device:
• Colonoscopy
A colonoscopy (procedure performed using a scope design to examine the large bowel) will be offered to the participants
• Upper endoscopy
An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants

Locations

Country	Name	City	State
Spain	Digestive Service, Huc	La Laguna	S/C DE Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Cubiella J, Salve M, Díaz-Ondina M, Vega P, Alves MT, Iglesias F, Sánchez E, Macía P, Blanco I, Bujanda L, Fernández-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. — View 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. — View 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. — View Citation

Quintero E, Carrillo M, Gimeno-García AZ, Hernández-Guerra M, Nicolás-Pérez D, Alonso-Abreu I, Díez-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. — View Citation

Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, Andreu M, Carballo F, Morillas JD, Hernández C, Jover R, Montalvo I, Arenas J, Laredo E, Hernández V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Roncales MP, Polo-Tomás M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Pérez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Díaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, González-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. Erratum in: N Engl J Med. 2016 May 12;374(19):1898. — View Citation

Rodríguez-Alonso L, Rodríguez-Moranta F, Ruiz-Cerulla A, Lobatón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with colorectal cancer among those with a positive immunochemical fecal test (Positive predictive value)	In order to calculate the positive predictive value, the number of patients with events (colorectal cancers) will be divided among the number of positive immunochemical fecal tests	one year
Secondary	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	In order to calculate the positive predictive value, the number of patients with a significant lesion (i.e. colorectal cancer, advanced adenoma, inflammatory bowel disease, angiodysplasia, gastric cancer, watermelon stomach, gastric/duodenal ulcer, ampulloma, erosive gastritis/duodenitis) will be divided among the number of positive immunochemical fecal tests.	one year
Secondary	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	In order to calculate the negative predictive value, the number of patients without a significant lesion will be divided among patients with a negative immunochemical fecal test	one year