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CellAdhesionMolecule EndometriosisRatio - CAMERA

Sponsor
Heinrich Husslein (Other)
Overall Status
Recruiting
CT.gov ID
NCT04294017
Collaborator
Medical-Scientific Fund of the Mayor of the Federal Capital Vienna (Other)
300
Enrollment
1
Location
62
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Endometriosis, which is characterized by the growth of endometrial stroma and glands outside of the uterine cavity, is estimated to occur in 6-10% of women of reproductive age. Clinical presentation of endometriosis can vary widely, often significantly reducing quality of life, and the mean interval between the onset of symptoms and obtaining a definitive diagnosis is approximately 10 years. Currently, laparoscopy is the gold standard for diagnosing endometriosis; however, this procedure is invasive, carries surgery-related risks, and contributes to diagnostic delay. Therefore, the field has an urgent need for an efficient, sensitive, non-invasive tool for diagnosing endometriosis.

Recently, it was shown that sVCAM-1/sICAM-1 ratio is a promising serum biomarker, which may lead to the development of a new, efficient, sensitive, non-invasive tool for diagnosing endometriosis, thereby potentially avoiding surgical interventions.

Primary aim: To determine whether the serum sVCAM-1/sICAM-1 ratio can be used todiagnose endometriosis.

Study design: Prospective multicenter validation study

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study
    Actual Study Start Date :
    Nov 1, 2017
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    participants undergoing a diagnostic laparoscopy and have a histologically confirmed Endometriosis
    controls

    participants undergoing a diagnostic laparoscopy where no evidence of Endometriosis could be found

    Outcome Measures

    Primary Outcome Measures

    1. sICAM and sVCAM in serum [up to 1 week]

      levels of these two soluble adhesion factors in serum of patients and controls

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • unfulfilled desire for children

    • chronic pelvic pain

    • suspicion of endometriosis

    • cysts

    • myomas

    Exclusion Criteria:

    • acute infections

    • malign diseases

    • drug abuse

    • pregnancy

    • infectious diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Vienna Vienna Austria

    Sponsors and Collaborators

    • Heinrich Husslein
    • Medical-Scientific Fund of the Mayor of the Federal Capital Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heinrich Husslein, Assoc.Prof.Priv.Doz Dr.med.univ. , PLL.M., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT04294017
    Other Study ID Numbers:
    • 1496/2017
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometriosis

    Study Results

    No Results Posted as of Feb 23, 2021