Endometriosis (Diagnosis)CAMERANCT04294017
CellAdhesionMolecule EndometriosisRatio - CAMERA
An observational study of Endometriosis (Diagnosis) and Identification of Biomarkers in Serum, run by Heinrich Husslein at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis (Diagnosis), Identification of Biomarkers in Serum
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2017to 31 Dec 2022
- How long will I take part?
- 2 Months
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women in reproductive age undergoing a diagnostic laparoscopy
Who may be able to join
- unfulfilled desire for children
- chronic pelvic pain
- suspicion of endometriosis
- cysts
- myomas
Who cannot join
- acute infections
- malign diseases
- drug abuse
- pregnancy
- infectious diseases
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna
Lorenz Kuessel, Dr., +434040049160, lorenz.kuessel@meduniwien.ac.at
Heinrich Husslein, Dr.
About this study
Official title: The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study
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.
Read more
Primary aim: To determine whether the serum sVCAM-1/sICAM-1 ratio can be used todiagnose endometriosis.
Study design: Prospective multicenter validation study
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
sICAM and sVCAM in serum
levels of these two soluble adhesion factors in serum of patients and controls
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Nov 2017
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis (Diagnosis)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Heinrich Husslein
- Sponsor type
- University, hospital or other
- Collaborators
- Medical-Scientific Fund of the Mayor of the Federal Capital Vienna
- Responsible party
- Sponsor-investigator, Heinrich Husslein, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294017
- Sponsor's protocol ID
- 1496/2017
- Acronym
- CAMERA
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study
- ClinicalTrials.gov ID
- NCT04294017
- Acronym / sponsor ID
- CAMERA / 1496/2017
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heinrich HussleinUniversity, hospital or other
- Collaborators
- Medical-Scientific Fund of the Mayor of the Federal Capital Vienna
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Mar 2020 (actual)
- 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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women in reproductive age undergoing a diagnostic laparoscopy
Key inclusion criteria (5 listed)
- unfulfilled desire for children
- chronic pelvic pain
- suspicion of endometriosis
- cysts
- myomas
Key exclusion criteria (5 listed)
- acute infections
- malign diseases
- drug abuse
- pregnancy
- infectious diseases
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
sICAM and sVCAM in serum
Time frame: up to 1 week
levels of these two soluble adhesion factors in serum of patients and controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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.
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 Endometriosis (Diagnosis) and Identification of Biomarkers in Serum, run by Heinrich Husslein at 1 site in Austria.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Kuessel, Dr. (+4314040049160, lorenz.kuessel@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sICAM and sVCAM in serum (time frame: up to 1 week). 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 23 Feb 2021.