Blood and Lymph Conditions

Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Digestive System Diseases

Anemia, Iron-Deficiency

Iron Deficiencies

Anemia

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematologic Diseases

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Micronutrients

All Drugs and Chemicals

Iron

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

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

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

Immunochemical fecal occult blood test

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

Colonoscopy

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

Upper endoscopy

Marta Carrillo, MD, PhD

ENRIQUE QUINTERO, MD. PhD.

Antonio Z Gimeno García, MD PhD

Zaida Adrián de Ganzo, MD PhD

David N Pérez, MD PhD

Marta Carrillo Palau, MD PhD

Enrique Quintero, MD, PhD

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.

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.

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

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

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

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.

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

Spots Global Cancer Trial Database for immunochemical occult blood test