ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis
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| First Received Date ICMJE | February 21, 2011 | ||||
| Last Updated Date | June 1, 2012 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01301885 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis | ||||
| Official Title ICMJE | Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications | ||||
| 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: serum, peritoneal fluid, endometrium tissue, healthy peritoneum, tissue of endometriosis (peritoneal, ovarian, deep infiltrating. Extracted DNA, RNA, cDNA and protein from the above samples. |
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| 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 |
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| Condition ICMJE | Endometriosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 230 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 19 Years to 48 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01301885 | ||||
| Other Study ID Numbers ICMJE | ENDOMET-231/2004 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Antti Perheentupa, Turku University Hospital | ||||
| Study Sponsor ICMJE | Turku University Hospital | ||||
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| Investigators ICMJE |
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| Information Provided By | Turku University Hospital | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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