ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis
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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 |
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 |
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
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| 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 | |
| Principal Investigator: | Antti Perheentupa, MD, PhD | Department of Obstetrics and Gynecology, Turku University Central Hospital |
More Information
Publications:
| Responsible Party: | Antti Perheentupa, Associate Professor, Turku University Hospital |
| ClinicalTrials.gov Identifier: | NCT01301885 History of Changes |
| Other Study ID Numbers: | ENDOMET-231/2004 |
| Study First Received: | February 21, 2011 |
| Last Updated: | June 1, 2012 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Turku University Hospital:
|
endometriosis dysmenorrhea infertility biomarker drug target |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013