Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
NCT Number: NCT02727075
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.
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Notify Me75 year and older
All sexes
Observational
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
Immunological testing will be performed systematically for each patient.
Research of blood in fecal sample will be based on 2 methods: one based on a qualitative immunochromatographic method (such as HemSign4 technique, Servibio, France; or all other techniques used at AP-HP) and another quantitative immunoturbidimetric method (OC-Sensor, Eiken, Japan). They will be performed systematically with two fresh fecal samples for each patient, before coloscopy examination.
Treating physicians will not be provided with the testing result. The diagnosis of reference will be established by experts based on the result of explorations (colonoscopy, coloscanner) and the patient's progression, blinded to the result of immunoassay.
The intrinsic characteristics of the immunoassay (sensitivity, specificity...) will be determined with reference to this reference diagnosis, using a positivity threshold defined using expert consensus on the weights to be allocated to potential errors.
2 modeling scenarios (without vs with immunological testing) using decision trees based on prevalence and diagnostic performance observed and stochastic simulations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline
The immunological test with OC-SENSOR supplies is a quantitative determination of hemoglobin, the method of detection of lower gastrointestinal hemorrhagic lesions of older population with iron deficiency anemia.
Sensitivity of the immunological test will be calculated statistically.
Time frame: At baseline
The immunological test with OC-SENSOR supplies is a quantitative determination of hemoglobin, the method of detection of lower gastrointestinal hemorrhagic lesions of older population with iron deficiency anemia.
Specificity of the immunological test will be calculated statistically.
Time frame: At baseline
The immunological test with OC-SENSOR supplies is a quantitative determination of hemoglobin, the method of detection of lower gastrointestinal hemorrhagic lesions of older population with iron deficiency anemia.
Likelihood rations of the immunological test will be calculated statistically.
Time frame: At baseline
Diagnostic Performance of predictive equation incorporating all individual data will be calculated statistically.
Time frame: At baseline
Compare using modeling (decision trees) the causal efficiency (number of origins of bleeding detected / number of coloscopy-colonoscopy performed) of two scenarios: without (base case) and with the immunoassay to research occult bleeding in feaces (with one or two fecal samples).
Time frame: At baseline
Sensitivity, specificity and likelihood ratios of the immunological testing will be calculated statistically, when an optimized positivity threshold for the population under study is used, as a function of weights (defined by experts consensus) allocated to errors (false negative and false positive cases).
Assistance Publique - Hôpitaux de Paris
Other
Acronym: STRATAGANEMIE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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