ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

NCT ID: NCT01301885

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2028-12-31

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.

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis

Women (19-48 years of age) with surgically confirmed endometriosis.

Laparoscopy/laparotomy

Intervention Type: PROCEDURE

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

Healthy women

Healthy women (32-48 years of age), symptom free, existence of endometriosis ruled out during laparoscopy for tubal ligation

Laparoscopy/laparotomy

Intervention Type: PROCEDURE

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

Interventions

Laparoscopy/laparotomy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

The Finnish Funding Agency for Technology and Innovation (TEKES)

OTHER_GOV

Sponsor Role: collaborator

VTT Technical Research Centre of Finland

OTHER

Sponsor Role: collaborator

Finnish Medical Foundation

NETWORK

Sponsor Role: collaborator

Hormos Medical

INDUSTRY

Sponsor Role: collaborator

PerkinElmer, Wallac Oy

INDUSTRY

Sponsor Role: collaborator

Biotop Oy

INDUSTRY

Sponsor Role: collaborator

Pharmatest Services Ltd

UNKNOWN

Sponsor Role: collaborator

Drug Discovery Graduate School, Finland

UNKNOWN

Sponsor Role: collaborator

The National Graduate School of Clinical Investigation, Finland

UNKNOWN

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Antti Perheentupa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antti Perheentupa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Turku University Central Hospital

Locations

Dept of Obstetrics and Gynecology, Helsinki University Hospital

Helsinki, , Finland

Site Status: COMPLETED

Dept of Obstetrics and Gynecology, North Carelia Central Hospital

Joensuu, , Finland

Site Status: COMPLETED

Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital

Lahti, , Finland

Site Status: COMPLETED

Dept of Obstetrics and Gynecology, Turku University Central Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Antti H Perheentupa, MD PhD

Role: CONTACT

antti.perheentupa@utu.fi

+358-2-3130000 ext. 30222

Kaisa Huhtinen, PhD

Role: CONTACT

kaisa.huhtinen@utu.fi

+358-2-333 7376

Facility Contacts

Antti Perheentupa, MD, PhD

Role: primary

References

Gabriel M, Fey V, Heinosalo T, Adhikari P, Rytkonen 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.

Reference Type: BACKGROUND

PMID: 32859947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29462326 (View on PubMed)

Huhtinen K, Suvitie P, Hiissa J, Junnila J, Huvila J, Kujari H, Setala M, Harkki P, Jalkanen J, Fraser J, Makinen J, Auranen A, Poutanen M, Perheentupa A. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts. Br J Cancer. 2009 Apr 21;100(8):1315-9. doi: 10.1038/sj.bjc.6605011. Epub 2009 Mar 31.

Reference Type: RESULT

PMID: 19337252 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19663710 (View on PubMed)

Hallamaa M, Suvitie P, Huhtinen K, Matomaki 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. doi: 10.1016/j.ygyno.2012.03.011. Epub 2012 Mar 14.

Reference Type: RESULT

PMID: 22426487 (View on PubMed)

Huhtinen K, Desai R, Stahle 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;97(11):4228-35. doi: 10.1210/jc.2012-1154. Epub 2012 Sep 11.

Reference Type: RESULT

PMID: 22969138 (View on PubMed)

Huhtinen K, Saloniemi-Heinonen T, Keski-Rahkonen P, Desai R, Laajala D, Stahle M, Hakkinen MR, Awosanya M, Suvitie P, Kujari H, Aittokallio T, Handelsman DJ, Auriola S, Perheentupa A, Poutanen M. Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions. J Clin Endocrinol Metab. 2014 Nov;99(11):E2188-97. doi: 10.1210/jc.2014-1913. Epub 2014 Aug 19.

Reference Type: RESULT

PMID: 25137424 (View on PubMed)

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 spectrometry analysis. J Proteome Res. 2014 Nov 7;13(11):4983-94. doi: 10.1021/pr500384n. Epub 2014 Aug 20.

Reference Type: RESULT

PMID: 25099244 (View on PubMed)

Other Identifiers

ENDOMET-231/2004

Identifier Type: -

Identifier Source: org_study_id