NCT02727075

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
Last Updated

March 18, 2025

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

March 8, 2016

Last Update Submit

March 17, 2025

Conditions

Occult Gastrointestinal Bleeding

Keywords

Occult Gastrointestinal BleedingIron Deficiency AnemiaAged 75 Years and Older

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    At baseline

Secondary Outcomes (3)

  • Diagnostic Performance

    At baseline

  • Comparing scenarios using decision trees

    At baseline

  • Performance of the test when used with an optimized positivity threshold

    At baseline

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

200 people at least 75 years old.

You may qualify if:

  • 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.

You may not qualify if:

  • Hematemesis or melena
  • Life expectancy inferior to 12 months
  • Patient has difficulty in follow-up of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Hépato-Gastroentérologie, Hôpital Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal Occult Blood Test

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dominique Lamarque, MD, PhD

    Service Hépato-Gastroentérologie, Hôpital Ambroise Paré

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

April 4, 2016

Study Start

July 1, 2016

Primary Completion

September 5, 2019

Study Completion

September 5, 2019

Last Updated

March 18, 2025

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)