ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Turku University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Turku
The Finnish Funding Agency for Technology and Innovation (TEKES)
VTT Technical Research Centre of Finland
Finnish Medical Foundation
Hormos Medical
PerkinElmer, Wallac Oy
Biotop Oy
Pharmatest Services Ltd
Drug Discovery Graduate School, Finland
The National Graduate School of Clinical Investigation, Finland
Information provided by (Responsible Party):
Antti Perheentupa, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01301885
First received: February 21, 2011
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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. Furthermore, combined with an adequate follow up, the study should enable for example to identify markers for endometriosis associated infertility as well as cases where the disease progresses very rapidly. Different forms of effective treatment may thereafter be designed following the identification of such factors.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Biospecimen Retention:   Samples With DNA

serum, peritoneal fluid, endometrium tissue, healthy peritoneum, tissue of endometriosis (peritoneal, ovarian, deep infiltrating.

Extracted DNA, RNA, cDNA and protein from the above samples.


Estimated Enrollment: 230
Study Start Date: October 2005
Groups/Cohorts
Endometriosis
Women (19-38 years of age) with surgically confirmed endometriosis
Healthy women
Healthy women (32-48 years of age), symptom free, existence of endometriosis ruled out during laparoscopy for tubal ligation

  Eligibility

Ages Eligible for Study:   19 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301885

Locations
Finland
Dept of Obstetrics and Gynecology, Helsinki University Hospital
Helsinki, Finland, 00029
Dept of Obstetrics and Gynecology, North Carelia Central Hospital
Joensuu, Finland, 80210
Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital
Lahti, Finland, 15850
Dept of Obstetrics and Gynecology, Turku University Central Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
University of Turku
The Finnish Funding Agency for Technology and Innovation (TEKES)
VTT Technical Research Centre of Finland
Finnish Medical Foundation
Hormos Medical
PerkinElmer, Wallac Oy
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