EndometriosisENDOMETNCT01301885
ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis
An observational study of Endometriosis, run by Turku University Hospital at 4 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 19 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Laparoscopy/laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 4 sitesFinland
- Study dates
- Oct 2005to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- study group: surgically and pathologically verified endometriosis
- control group: existence of endometriosis ruled out in laparoscopy
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 1 recruiting
- Completed
Dept of Obstetrics and Gynecology, Helsinki University Hospital
Helsinki, 00029
- Completed
Dept of Obstetrics and Gynecology, North Carelia Central Hospital
Joensuu, 80210
- Completed
Dept of Obstetrics and Gynecology, Päijät-Häme Central Hospital
Lahti, 15850
- Recruiting
Dept of Obstetrics and Gynecology, Turku University Central Hospital
Turku, 20520
Antti Perheentupa, MD, PhD
Kaisa Huhtinen, PhD
About this study
Official title: 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. 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
- Being tested
- Laparoscopy/laparotomy
- Keywords
- endometriosis, dysmenorrhea, infertility, biomarker, drug target, recurrence, complications, dyspareunia, dyschezia, dysuria, chronic pelvic pain, surgical treatment, long-term follow-up
- Medical subject headings
- Endometriosis, Dysmenorrhea, Infertility, Recurrence, Dyspareunia, Constipation, Dysuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy/laparotomyProcedure or surgery
Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Women (19-48 years of age) with surgically confirmed endometriosis. Receives: Procedure: Laparoscopy/laparotomy | |
| Healthy women | Healthy women (32-48 years of age), symptom free, existence of endometriosis ruled out during laparoscopy for tubal ligation Receives: Procedure: Laparoscopy/laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions.
Measured: During the surgical sample collection
Endometrial and endometriotic concentrations of estrone and estradiol are determined by local metabolism rather than circulating levels.
Measured: During the surgical sample collection
Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts.
Measured: During the surgical sample collection
A relational database to identify differentially expressed genes in the endometrium and endometriosis lesions
Measured: During the surgical sample collection
Secondary outcomes (2)
A prospective 5-year follow-up of pain recurrence after surgical treatment of endometriosis
Questionnaire based evaluation of postoperative pain symptoms
Measured: 5 years (annually) after the completion of patient recruitment
Serum HE-4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women
Measured: During surgical sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startOct 2005
- Primary completionDec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, The Finnish Funding Agency for Technology and Innovation, 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
- Responsible party
- Principal investigator, Antti Perheentupa, Turku University Hospital
- Investigators
- Antti Perheentupa, MD, PhD, Principal investigator, Department of Obstetrics and Gynecology, Turku University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301885
- Sponsor's protocol ID
- ENDOMET-231/2004
- Acronym
- ENDOMET
- Status last verified
- Aug 2021
- First submitted
- 21 Feb 2011
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32859947Heinosalo 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.
PubMed 29462326Huhtinen 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.
PubMed 19337252Hiissa 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.
PubMed 19663710Hallamaa 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.
PubMed 22426487Huhtinen 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.
PubMed 22969138Huhtinen 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.
PubMed 25137424Vehmas 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.
PubMed 25099244
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications
- ClinicalTrials.gov ID
- NCT01301885
- Acronym / sponsor ID
- ENDOMET / ENDOMET-231/2004
- Conditions
- Endometriosis
- Keywords
- endometriosis, dysmenorrhea, infertility, biomarker, drug target, recurrence, complications, dyspareunia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, The Finnish Funding Agency for Technology and Innovation, 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
- Study start
- Oct 2005
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Procedure: Laparoscopy/laparotomyWomen (19-48 years of age) with surgically confirmed endometriosis. |
| Healthy women | – | Procedure: Laparoscopy/laparotomyHealthy women (32-48 years of age), symptom free, existence of endometriosis ruled out during laparoscopy for tubal ligation |
Who may qualify
- Ages
- 19 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- study group: surgically and pathologically verified endometriosis
- control group: existence of endometriosis ruled out in laparoscopy
Key exclusion criteria (6 listed)
- no other significant disease or medication for other diseases
- suspicion of malignancy
- pregnancy
- acute infection
- insufficient understanding of Finnish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopy/laparotomySurgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups. | Procedure or surgery | Endometriosis, Healthy women |
Primary outcome
Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions.
Time frame: During the surgical sample collection
Endometrial and endometriotic concentrations of estrone and estradiol are determined by local metabolism rather than circulating levels.
Time frame: During the surgical sample collection
Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts.
Time frame: During the surgical sample collection
A relational database to identify differentially expressed genes in the endometrium and endometriosis lesions
Time frame: During the surgical sample collection
2 secondary outcomes
A prospective 5-year follow-up of pain recurrence after surgical treatment of endometriosis
Time frame: 5 years (annually) after the completion of patient recruitment
Serum HE-4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women
Time frame: During surgical sample collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Background: PubMed 32859947Gabriel 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.
- Background: PubMed 29462326Heinosalo 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.
- Results publication: PubMed 19337252Huhtinen 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.
- Results publication: PubMed 19663710Hiissa 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.
- Results publication: PubMed 22426487Hallamaa 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.
- Results publication: PubMed 22969138Huhtinen 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.
- Results publication: PubMed 25137424Huhtinen 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.
- Results publication: PubMed 25099244Vehmas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antti Perheentupa, MD, PhD principal investigator
Department of Obstetrics and Gynecology, Turku University Central Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Turku University Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antti H Perheentupa, MD PhD (+358-2-3130000 ext. 30222, antti.perheentupa@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions. (time frame: During the surgical sample collection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01301885, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.