NCT01301885 ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis
| NCT ID | NCT01301885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2005-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2005-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 * suspicion of malignancy * pregnancy * acute infection * insufficient understanding of Finnish language * previous hysterectomy and/or bilateral salpingo-oophorectomy
Contact & Investigator
Antti Perheentupa, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Obstetrics and Gynecology, Turku University Central Hospital
Frequently Asked Questions
Who can join the NCT01301885 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 48 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01301885 currently recruiting?
Yes, NCT01301885 is actively recruiting participants. Contact the research team at antti.perheentupa@utu.fi for enrollment information.
Where is the NCT01301885 trial being conducted?
This trial is being conducted at Helsinki, Finland, Joensuu, Finland, Lahti, Finland, Turku, Finland.
Who is sponsoring the NCT01301885 clinical trial?
NCT01301885 is sponsored by Turku University Hospital. The principal investigator is Antti Perheentupa, MD, PhD at Department of Obstetrics and Gynecology, Turku University Central Hospital. The trial plans to enroll 230 participants.