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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Stockholm South General Hospital | OTHER |
| Uppsala University Hospital | OTHER |
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Endometriosis is a chronic, benign, estrogen-dependent disease characterized by endometrial tissue that is implanted outside the uterus into the ovaries, intestines, or peritoneum but also outside the pelvis. It is a common disease that affects 7-10% of women around the world. The most common symptoms are pain and infertility. The diagnosis is histological after removal of lesions with laparoscopy (sensitivity 94%, specificity 79%), and treatment is symptomatic.
At present, there is not a laboratory test that allows early and adequate diagnosis of endometriosis and therefore it can take up to 10 years for a patient to be diagnosed and patients often suffer from the disease.
The purpose of our study is to investigate biomarkers associated with endometriosis and prove their use in the diagnosis and staging of endometriosis. The biomarkers will be studied even in relationship to clinical manifestations of the disease, as markers of relapse and as fertility markers. Meanwhile, quality of life of patients with advanced stages of endometriosis postoperatively will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe/Deep infiltrating endometriosis | Endometriosis stage III/IV according to rASRM. |
| |
| Minimal/mild endometriosis | Endometriosis stage I/II according to rASRM |
| |
| Controls | Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood biomarkers | Diagnostic Test | Blood biomarkers in plasma and serum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94% | Blood biomarkers as endometriosis diagnostic tests | Preoperative |
| Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis. | Blood biomarkers as a relapse marker | 3-6 months postoperative in the severe/DIE group |
| Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79% | Blood biomarkers as endometriosis diagnostic tests | Preoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patients undergoing surgery for DIE | Endometriosis Health Profile 30 Questionnaire | Preoperative and 3-6 months postoperative in the severe/DIE group |
| Achieved pregnancy postoperative |
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IInclusion Criteria:
Exclusion Criteria:
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Participants will be recruited in several gynecological clinics around Sweden. A total of 345 women of reproductive age will be included in the study according to the power calculation. 115 patients who are operated on due to deep infiltrating endometriosis or rASRM III-IV in national endometriosis centers in Sweden, 115 patients who are diagnosed during surgery with early-stage endometriosis (rASRM I-II) and 115 patients who are controls, who are operated on for others benign gynecological diseases (fibroids, ovarian cysts, chronic abdominal pain, sterilization) and have no signs of endometriosis perioperatively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Drakou, MSc | Contact | 0046 735500118 | anastasia.drakou@regionstockholm.se | |
| Kenny Rodriguez-Wallberg, Professor | Contact | kenny.rodriguez-wallberg@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Kenny Rodriguez-Wallberg, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Universitetssjukhus Huddinge | Recruiting | Stockholm | Huddinge | Sweden |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Positive pregnancy test
| One year postoperative |
| Södersjukhuset Kvinnokliniken | Recruiting | Stockholm | Stockholm County | Sweden |
|
| Akademiska Uppsala | Not yet recruiting | Uppsala | Sweden |
|
| D000091662 | Genital Diseases |