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Trial record 1 of 1 for:    Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia
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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 : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Tracking Information
First Submitted Date  ICMJE May 20, 2016
First Posted Date  ICMJE June 7, 2016
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE June 30, 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)
Official Title  ICMJE Usefulness of Fecal Immunochemical Test in the Diagnosis Algorithm of Iron Deficiency Anemia.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Colonoscopy followed by upper endoscopy
    In case of a positive immunochemical fecal occult blood test result, colonoscopy will be the first examination
    Interventions:
    • Other: Immunochemical fecal occult blood test
    • Device: Colonoscopy
    • Device: Upper endoscopy
  • Upper endoscopy followed by colonoscopy
    In case of a negative immunochemical fecal occult blood test result, upper endoscopy will be the first examination
    Interventions:
    • Other: Immunochemical fecal occult blood test
    • Device: Colonoscopy
    • Device: Upper endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marta Carrillo, MD, PhD 34-922678000 ext 34039 martacarry@yahoo.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02792023
Other Study ID Numbers  ICMJE FIT-Iron deficiency anemia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Universitario de Canarias
Study Sponsor  ICMJE Hospital Universitario de Canarias
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Enrique Quintero, MD, PhD Hospital Universitario de Canarias
PRS Account Hospital Universitario de Canarias
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP