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NCT01301885Recruiting

ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

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

Source: ClinicalTrials.gov · Last updated 16 Aug 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
230 (estimated)
First submitted
21 Feb 2011
Start date
Oct 2005
Primary completion date
Dec 2025
Lead sponsor
Turku University Hospital
NCT number
NCT01301885

What you commit to

  • Study type: Observational
  • Planned participants: 230
  • From Oct 2005 to the primary completion date, Dec 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous hysterectomy and/or bilateral salpingo-oophorectomy

Other illness

  • no other significant disease or medication for other diseases
  • suspicion of malignancy
  • acute infection

Other

  • pregnancy
  • insufficient understanding of Finnish language

Who the study is looking for

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

Age in the registry: 19 years to 48 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dept of Obstetrics and Gynecology, Helsinki University Hospital
Coordinator of this site? Confirm its status
HelsinkiFinlandCompleted
Dept of Obstetrics and Gynecology, North Carelia Central Hospital
Coordinator of this site? Confirm its status
JoensuuFinlandCompleted
Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital
Coordinator of this site? Confirm its status
LahtiFinlandCompleted
Dept of Obstetrics and Gynecology, Turku University Central Hospital
Coordinator of this site? Confirm its status
TurkuFinlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.