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

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ClinicalTrials.gov Identifier: NCT02792023
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Immunochemical fecal occult blood test Device: Colonoscopy Device: Upper endoscopy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Usefulness of Fecal Immunochemical Test in the Diagnosis Algorithm of Iron Deficiency Anemia.
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. The number of patients with colorectal cancer among those with a positive immunochemical fecal test (Positive predictive value) [ Time Frame: one year ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: one year ]
    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.

  2. 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 [ Time Frame: one year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792023


Contacts
Contact: Marta Carrillo, MD, PhD 34-922678000 ext 34039 martacarry@yahoo.es

Locations
Spain
Digestive Service, Huc Recruiting
La Laguna, S/c de Tenerife, Spain, 38320
Contact: ENRIQUE QUINTERO, MD. PhD.    615553711    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         
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Study Director: Enrique Quintero, MD, PhD Hospital Universitario de Canarias

Publications:

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT02792023     History of Changes
Other Study ID Numbers: FIT-Iron deficiency anemia
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Hospital Universitario de Canarias:
Colorectal cancer
Immunochemical occult blood test

Additional relevant MeSH terms:
Colorectal Neoplasms
Anemia, Iron-Deficiency
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases