Occult Gastrointestinal BleedingSTRATAGANEMIENCT02727075
Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years
An observational study of Occult Gastrointestinal Bleeding, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Occult Gastrointestinal Bleeding
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 5 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 200 people at least 75 years old.
Who may be able to join
- 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.
Who cannot join
- Hematemesis or melena
- Life expectancy inferior to 12 months
- Patient has difficulty in follow-up of study.
Trial locations and contacts
1 site in 1 country.
France1 site
Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100
About this study
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.
Read the detailed description
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.
- Conditions
- Occult Gastrointestinal Bleeding
- Keywords
- Occult Gastrointestinal Bleeding, Iron Deficiency Anemia, Aged 75 Years and Older
- Medical subject headings
- Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of immunological test with OC-SENSOR supplies
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.
Measured: At baseline
Specificity of immunological test with OC-SENSOR supplies
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.
Measured: At baseline
Likelihood ratios of immunological test with OC-SENSOR supplies
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.
Measured: At baseline
Secondary outcomes (3)
Diagnostic Performance
Diagnostic Performance of predictive equation incorporating all individual data will be calculated statistically.
Measured: At baseline
Comparing scenarios using decision trees
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).
Measured: At baseline
Performance of the test when used with an optimized positivity threshold
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).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occult Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Lamarque, MD, PhD, Study director, Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727075
- Sponsor's protocol ID
- P140307
- Other IDs
- AOR14082
- Acronym
- STRATAGANEMIE
- Status last verified
- Feb 2021
- First submitted
- 8 Mar 2016
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years
- ClinicalTrials.gov ID
- NCT02727075
- Acronym / sponsor ID
- STRATAGANEMIE / P140307
- Conditions
- Occult Gastrointestinal Bleeding
- Keywords
- Occult Gastrointestinal Bleeding, Iron Deficiency Anemia, Aged 75 Years and Older
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 200 people at least 75 years old.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Hematemesis or melena
- Life expectancy inferior to 12 months
- Patient has difficulty in follow-up of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of immunological test with OC-SENSOR supplies
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.
Specificity of immunological test with OC-SENSOR supplies
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.
Likelihood ratios of immunological test with OC-SENSOR supplies
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.
3 secondary outcomes
Diagnostic Performance
Time frame: At baseline
Comparing scenarios using decision trees
Time frame: At baseline
Performance of the test when used with an optimized positivity threshold
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Occult Gastrointestinal Bleeding
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Not yet recruitingObservational study
How Often Does the Fecal Test for Occult Blood Turn Positive After Using Blood Thinners?
Gastrointestinal Bleeding, Antiplatelet Agents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Lamarque, MD, PhD study director
Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occult Gastrointestinal Bleeding, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of immunological test with OC-SENSOR supplies (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.