ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

NCT01301885 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2021-08-16

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

PROCEDURE

Laparoscopy/laparotomy

Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER
  • The Finnish Funding Agency for Technology and Innovation (TEKES)

    collaborator OTHER_GOV
  • VTT Technical Research Centre of Finland

    collaborator OTHER
  • Finnish Medical Foundation

    collaborator NETWORK
  • Hormos Medical

    collaborator INDUSTRY
  • PerkinElmer, Wallac Oy

    collaborator INDUSTRY
  • Biotop Oy

    collaborator INDUSTRY
  • Pharmatest Services Ltd

    collaborator UNKNOWN
  • Drug Discovery Graduate School, Finland

    collaborator UNKNOWN
  • The National Graduate School of Clinical Investigation, Finland

    collaborator UNKNOWN
  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Antti Perheentupa, MD, PhD · Department of Obstetrics and Gynecology, Turku University Central Hospital

Eligibility

Min Age
19 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2025-12-31
Completion
2028-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01301885 on ClinicalTrials.gov