ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis (ENDOMET)

August 9, 2021 updated by: Antti Perheentupa, Turku University Hospital

Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications

Endometriosis is a chronic disease characterized by the presence of functional endometrial glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial tissue responds to estradiol and other hormones similarly to the normal endometrium. Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of women in the reproductive age may be affected. In addition to pain which may be severe, subfertility is one of the typical problems associated with endometriosis and may be present in up to 40% of those affected. There is lack of a clear correlation between severity of pain and degree of compromised fertility. Different modes of treatment exist. Hormonal treatments are based on the suppression of estrogenic action on endometriosis as well as the endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of time, however, curative treatment frequently involves hysterectomy with bilateral oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of novel pharmacological agents would be of crucial importance. Presently, endometriosis can be reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is presently impossible to predict, new markers for the "malignancy" of each case are desperately needed.

The aim of the investigators research is to identify expression of endometriosis specific RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium of patients with careful clinical and surgical classification of endometriosis as well as healthy control women should initially enable to identify novel targets for new therapies and biomarkers. Particularly the different pain symptoms will be recorded annually and evaluated comprehensively. Furthermore, combined with an adequate 10-year follow up (based on a questionnaire, including fertility, received treatments and different pain symptoms; NRS), the study should enable for example to identify markers for endometriosis associated infertility as well as cases where the disease progresses very rapidly or reoccurs. Different forms of effective treatment may thereafter be designed following the identification of such factors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Completed
        • Dept of Obstetrics and Gynecology, Helsinki University Hospital
      • Joensuu, Finland, 80210
        • Completed
        • Dept of Obstetrics and Gynecology, North Carelia Central Hospital
      • Lahti, Finland, 15850
        • Completed
        • Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital
      • Turku, Finland, 20520
        • Recruiting
        • Dept of Obstetrics and Gynecology, Turku University Central Hospital
        • Contact:
          • Antti Perheentupa, MD, PhD
        • Sub-Investigator:
          • Kaisa Huhtinen, PhD
        • Sub-Investigator:
          • Pia Suvitie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Endometriosis: Finnish Caucasian women surgically treated for endometriosis; age 19-48, no significant other disease or medication for other diseases

Healthy controls: symptomless Finnish Caucasian women going through laparoscopy for tubal ligation; age 32-48, no significant other disease or medication

Description

Inclusion Criteria:

  • study group: surgically and pathologically verified endometriosis
  • control group: existence of endometriosis ruled out in laparoscopy

Exclusion Criteria:

  • no other significant disease or medication for other diseases
  • suspicion of malignancy
  • pregnancy
  • acute infection
  • insufficient understanding of Finnish language
  • previous hysterectomy and/or bilateral salpingo-oophorectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometriosis
Women (19-48 years of age) with surgically confirmed endometriosis.
Procedure: Laparoscopy/laparotomy
Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.
Healthy women
Healthy women (32-48 years of age), symptom free, existence of endometriosis ruled out during laparoscopy for tubal ligation
Procedure: Laparoscopy/laparotomy
Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions.
Time Frame: During the surgical sample collection
During the surgical sample collection
Endometrial and endometriotic concentrations of estrone and estradiol are determined by local metabolism rather than circulating levels.
Time Frame: During the surgical sample collection
During the surgical sample collection
Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts.
Time Frame: During the surgical sample collection
During the surgical sample collection
A relational database to identify differentially expressed genes in the endometrium and endometriosis lesions
Time Frame: During the surgical sample collection
During the surgical sample collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A prospective 5-year follow-up of pain recurrence after surgical treatment of endometriosis
Time Frame: 5 years (annually) after the completion of patient recruitment
Questionnaire based evaluation of postoperative pain symptoms
5 years (annually) after the completion of patient recruitment
Serum HE-4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women
Time Frame: During surgical sample collection
During surgical sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku
Hormos Medical
VTT Technical Research Centre of Finland
The Finnish Funding Agency for Technology and Innovation (TEKES)
PerkinElmer, Wallac Oy
Finnish Medical Foundation
Biotop Oy
Pharmatest Services Ltd
Drug Discovery Graduate School, Finland
The National Graduate School of Clinical Investigation, Finland

Investigators

  • Principal Investigator: Antti Perheentupa, MD, PhD, Department of Obstetrics and Gynecology, Turku University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDOMET-231/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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