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

NCT02792023 | Unknown DMC

• 1 other identifier: FIT-Iron deficiency anemia
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Immunochemical occult blood test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  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

  one year

Study Arms (2)

Colonoscopy followed by upper endoscopy

OTHER

In case of a positive immunochemical fecal occult blood test result, colonoscopy will be the first examination

Other: Immunochemical fecal occult blood test; Device: Colonoscopy; Device: Upper endoscopy

Upper endoscopy followed by colonoscopy

OTHER

In case of a negative immunochemical fecal occult blood test result, upper endoscopy will be the first examination

Other: Immunochemical fecal occult blood test; Device: Colonoscopy; Device: Upper endoscopy

Interventions

Immunochemical fecal occult blood test OTHER

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

Colonoscopy followed by upper endoscopy; Upper endoscopy followed by colonoscopy

Colonoscopy DEVICE

A colonoscopy (procedure performed using a scope design to examine the large bowel) will be offered to the participants

Colonoscopy followed by upper endoscopy; Upper endoscopy followed by colonoscopy

Upper endoscopy DEVICE

An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants

Colonoscopy followed by upper endoscopy; Upper endoscopy followed by colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Digestive Service, Huc

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 16215432 BACKGROUND

• 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.

  PMID: 18219289 BACKGROUND

• 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.

  PMID: 22356323 BACKGROUND

• 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.

  PMID: 25127679 BACKGROUND

• 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.

  PMID: 26055489 BACKGROUND

• 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.

  PMID: 24456168 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Gastroscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Enrique Quintero, MD, PhD

  Hospital Universitario de Canarias

  STUDY DIRECTOR

Central Study Contacts

Marta Carrillo, MD, PhD

CONTACT

34-922678000; martacarry@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 7, 2016
• Study Start: June 30, 2016
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

ES (1)