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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

February 21, 2011
June 1, 2012
October 2005
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Complete list of historical versions of study NCT01301885 on ClinicalTrials.gov Archive Site
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ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis
Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications

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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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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.

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

Endometriosis
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  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
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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
Female
19 Years to 48 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01301885
ENDOMET-231/2004
No
Antti Perheentupa, Turku University Hospital
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
Principal Investigator: Antti Perheentupa, MD, PhD Department of Obstetrics and Gynecology, Turku University Central Hospital
Turku University Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP