ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

Endometriosis Clinical Trial

— ENDOMET  

Official title:

Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01301885
• Other study ID #: ENDOMET-231/2004
• Status: Recruiting
• Start date: October 2005
• Est. completion date: December 2028

Study information

• Verified date: August 2021
• Source: Turku University Hospital
• Contact: Antti H Perheentupa, MD PhD
• Phone: +358-2-3130000
• Email: antti.perheentupa[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Laparoscopy/laparotomy
Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.

Locations

Country	Name	City	State
Finland	Dept of Obstetrics and Gynecology, Helsinki University Hospital	Helsinki
Finland	Dept of Obstetrics and Gynecology, North Carelia Central Hospital	Joensuu
Finland	Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital	Lahti
Finland	Dept of Obstetrics and Gynecology, Turku University Central Hospital	Turku

Sponsors (11)

Lead Sponsor	Collaborator
Turku University Hospital	Biotop Oy, Drug Discovery Graduate School, Finland, Finnish Medical Foundation, Hormos Medical, PerkinElmer, Wallac Oy, Pharmatest Services Ltd, The Finnish Funding Agency for Technology and Innovation (TEKES), The National Graduate School of Clinical Investigation, Finland, University of Turku, VTT Technical Research Centre of Finland

Country where clinical trial is conducted

Finland, 

References & Publications (8)

Gabriel M, Fey V, Heinosalo T, Adhikari P, Rytkönen K, Komulainen T, Huhtinen K, Laajala TD, Siitari H, Virkki A, Suvitie P, Kujari H, Aittokallio T, Perheentupa A, Poutanen M. A relational database to identify differentially expressed genes in the endometrium and endometriosis lesions. Sci Data. 2020 Aug 28;7(1):284. doi: 10.1038/s41597-020-00623-x. — View Citation

Hallamaa M, Suvitie P, Huhtinen K, Matomäki J, Poutanen M, Perheentupa A. Serum HE4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women. Gynecol Oncol. 2012 Jun;125(3):667-72 — View Citation

Heinosalo T, Gabriel M, Kallio L, Adhikari P, Huhtinen K, Laajala TD, Kaikkonen E, Mehmood A, Suvitie P, Kujari H, Aittokallio T, Perheentupa A, Poutanen M. Secreted frizzled-related protein 2 (SFRP2) expression promotes lesion proliferation via canonical WNT signaling and indicates lesion borders in extraovarian endometriosis. Hum Reprod. 2018 May 1;33(5):817-831. doi: 10.1093/humrep/dey026. — View Citation

Hiissa J, Elo LL, Huhtinen K, Perheentupa A, Poutanen M, Aittokallio T. Resampling reveals sample-level differential expression in clinical genome-wide studies. OMICS. 2009 Oct;13(5):381-96. doi: 10.1089/omi.2009.0027. — View Citation

Huhtinen K, Desai R, Ståhle M, Salminen A, Handelsman DJ, Perheentupa A, Poutanen M. Endometrial and endometriotic concentrations of estrone and estradiol are determined by local metabolism rather than circulating levels. J Clin Endocrinol Metab. 2012 Nov — View Citation

Huhtinen K, Saloniemi-Heinonen T, Keski-Rahkonen P, Desai R, Laajala D, Ståhle M, Häkkinen MR, Awosanya M, Suvitie P, Kujari H, Aittokallio T, Handelsman DJ, Auriola S, Perheentupa A, Poutanen M. Intra-tissue steroid profiling indicates differential proge — View Citation

Huhtinen K, Suvitie P, Hiissa J, Junnila J, Huvila J, Kujari H, Setälä M, Härkki P, Jalkanen J, Fraser J, Mäkinen J, Auranen A, Poutanen M, Perheentupa A. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts. B — View Citation

Vehmas AP, Muth-Pawlak D, Huhtinen K, Saloniemi-Heinonen T, Jaakkola K, Laajala TD, Kaprio H, Suvitie PA, Aittokallio T, Siitari H, Perheentupa A, Poutanen M, Corthals GL. Ovarian endometriosis signatures established through discovery and directed mass sp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions.		During the surgical sample collection
Primary	Endometrial and endometriotic concentrations of estrone and estradiol are determined by local metabolism rather than circulating levels.		During the surgical sample collection
Primary	Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts.		During the surgical sample collection
Primary	A relational database to identify differentially expressed genes in the endometrium and endometriosis lesions		During the surgical sample collection
Secondary	A prospective 5-year follow-up of pain recurrence after surgical treatment of endometriosis	Questionnaire based evaluation of postoperative pain symptoms	5 years (annually) after the completion of patient recruitment
Secondary	Serum HE-4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women		During surgical sample collection