CellAdhesionMolecule EndometriosisRatio - CAMERA

NCT ID: NCT04294017

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Endometriosis (Diagnosis) Identification of Biomarkers in Serum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

participants undergoing a diagnostic laparoscopy and have a histologically confirmed Endometriosis

No interventions assigned to this group

controls

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical-Scientific Fund of the Mayor of the Federal Capital Vienna

UNKNOWN

Sponsor Role collaborator

Heinrich Husslein

OTHER

Sponsor Role lead

Responsible Party

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Heinrich Husslein

Assoc.Prof.Priv.Doz Dr.med.univ. , PLL.M.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Medical University Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Lorenz Kuessel, Dr.

Role: CONTACT

+4314040049160

Facility Contacts

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Lorenz Kuessel, Dr.

Role: primary

+434040049160

Heinrich Husslein, Dr.

Role: backup

Other Identifiers

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1496/2017

Identifier Type: -

Identifier Source: org_study_id

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