Actively Recruiting

Age: 19Years - 48Years
FEMALE
Healthy Volunteers
NCT01301885

ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

Led by Turku University Hospital · Updated on 2021-08-16

230

Participants Needed

4

Research Sites

1208 weeks

Total Duration

On this page

Sponsors

T

Turku University Hospital

Lead Sponsor

U

University of Turku

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

Who Can Participate

Age: 19Years - 48Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Surgically and pathologically confirmed endometriosis for the study group
  • No endometriosis found by laparoscopy for the control group
Not Eligible

You will not qualify if you...

  • Presence of other significant diseases or use of medications for other diseases
  • Suspicion of cancer
  • Pregnancy
  • Acute infection
  • Insufficient understanding of the Finnish language
  • Previous hysterectomy or removal of both ovaries and fallopian tubes

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Dept of Obstetrics and Gynecology, Helsinki University Hospital

Helsinki, Finland, 00029

Completed

2

Dept of Obstetrics and Gynecology, North Carelia Central Hospital

Joensuu, Finland, 80210

Completed

3

Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital

Lahti, Finland, 15850

Completed

4

Dept of Obstetrics and Gynecology, Turku University Central Hospital

Turku, Finland, 20520

Actively Recruiting

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Research Team

A

Antti H Perheentupa, MD PhD

CONTACT

K

Kaisa Huhtinen, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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