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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Immunochemical fecal occult blood test; Device: Colonoscopy; Device: Upper endoscopy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Carrillo, MD, PhD; Phone Number: 34039 34-922678000; Email: martacarry@yahoo.es

Study Locations

• Spain
  • S/C DE Tenerife
    • La Laguna, S/C DE Tenerife, Spain, 38320
      • Recruiting
      • Digestive Service, Huc
      • Contact: ENRIQUE QUINTERO, MD. PhD.; Phone Number: 615553711; Email: equintero@gmail.com
      • Principal Investigator: ENRIQUE QUINTERO, MD. PhD.
      • Sub-Investigator: Antonio Z Gimeno García, MD PhD
      • Sub-Investigator: Zaida Adrián de Ganzo, MD PhD
      • Sub-Investigator: David N Pérez, MD PhD
      • Sub-Investigator: Marta Carrillo Palau, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Colonoscopy followed by upper endoscopy; In case of a positive immunochemical fecal occult blood test result, colonoscopy will be the first examination	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; Device: Upper endoscopy; An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants
OTHER: Upper endoscopy followed by colonoscopy; In case of a negative immunochemical fecal occult blood test result, upper endoscopy will be the first examination	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; Device: Upper endoscopy; An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: N Engl J Med. 2016 May 12;374(19):1898.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2016
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 17, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Colorectal cancer; Immunochemical occult blood test
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Colorectal Neoplasms; Anemia, Iron-Deficiency
• Other Study ID Numbers: FIT-Iron deficiency anemia