CompletedNot Applicable

Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years

France79 participantsStarted 2016-07

Plain-language summary

This study aims to characterize the diagnostic performance of immunological testing of occult gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency anemia. As secondary objectives, the study aims to: * determine a threshold of positivity optimizing the immunoassay performance for the study population, in accordance with the probabilities of error (false positives, false negatives) and weights (defined by expert consensus) allocated to these errors. * Assess the benefit of a double measure of bleeding (two stools) by immunoassay compared to a single measure.

Who can participate

Age range75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Physical status score 3 or 4, aged 75 and older patient, (patients under guardianship may be included). * Iron deficiency anemia (Hb≤120 g/l for a woman or Hb≤130 g/l for a man), and nonregenerative anemia with reticulocytes \<120 000/mm3. * Patient who has indication for colonoscopy and / or colonography examination, whatever the results of gastroscopy if performed. * Have a health insurance. * Informed consent signed. Exclusion Criteria: * Hematemesis or melena * Life expectancy inferior to 12 months * Patient has difficulty in follow-up of study.

What they're measuring

Sensitivity of immunological test with OC-SENSOR supplies

Timeframe: At baseline

Specificity of immunological test with OC-SENSOR supplies

Timeframe: At baseline

Likelihood ratios of immunological test with OC-SENSOR supplies

Timeframe: At baseline

Trial details

NCT IDNCT02727075

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-09-05

View on ClinicalTrials.gov More Occult Gastrointestinal Bleeding trials

Plain-language summary

Who can participate

Age range75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.