EndometriosisENDOBIONCT05339451
Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)
An observational study of Endometriosis, run by Region Stockholm at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Blood biomarkers
- Type of treatment
- Injection or infusion
- How many people
- 345 participants
- Where
- 3 sitesSweden
- Study dates
- 4 May 2023to 31 Dec 2026
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- BMI> 40
- postmenopausal women
- premature ovarian failure
- pelvic inflammatory disease (PID)
- current or previous malignancy
- pregnancy and 6 months postpartum
Show all 10Show fewer
- corticosteroids in the last 3 months
- pituitary, kidney, liver, adrenal disease
- endometrial hyperplasia or endometrial polyp
- cardiovascular or systemic inflammatory diseases.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenny Rodriguez-Wallberg, Professor contact
Sweden3 sites, 3 recruiting
- Recruiting
Karolinska Universitetssjukhus Huddinge
Stockholm, Huddinge
Anastasia Drakou
- Recruiting
Södersjukhuset Kvinnokliniken
Stockholm, Stockholm County
Malin Brunes, PhD
- Not yet recruiting
Akademiska Uppsala
Uppsala
Christine Asciutto, PhD
About this study
Official title: Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)
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.
- Conditions
- Endometriosis
- Being tested
- Blood biomarkers
- Keywords
- endometriosis, biomarkers
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood biomarkersDiagnostic test
Blood biomarkers in plasma and serum.
| Study group | Role | What they receive |
|---|---|---|
| Severe/Deep infiltrating endometriosis | Endometriosis stage III/IV according to rASRM. Receives: Diagnostic Test: Blood biomarkers | |
| Minimal/mild endometriosis | Endometriosis stage I/II according to rASRM Receives: Diagnostic Test: Blood biomarkers | |
| Controls | Women operated for other benign gynecological diseases and have no signs of endometriosis perioperatively. Receives: Diagnostic Test: Blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%
Blood biomarkers as endometriosis diagnostic tests
Measured: Preoperative
Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis.
Blood biomarkers as a relapse marker
Measured: 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
Measured: Preoperative
Secondary outcomes (2)
Quality of life of patients undergoing surgery for DIE
Endometriosis Health Profile 30 Questionnaire
Measured: Preoperative and 3-6 months postoperative in the severe/DIE group
Achieved pregnancy postoperative
Positive pregnancy test
Measured: One year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start4 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Stockholm South General Hospital, Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Kenny Rodriguez-Wallberg, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339451
- Sponsor's protocol ID
- K 2022-2797
- Acronym
- ENDOBIO
- Status last verified
- Feb 2025
- First submitted
- 5 Apr 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)
- ClinicalTrials.gov ID
- NCT05339451
- Acronym / sponsor ID
- ENDOBIO / K 2022-2797
- Conditions
- Endometriosis
- Keywords
- endometriosis, biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet, Stockholm South General Hospital, Uppsala University Hospital
- Study start
- 4 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2022 (actual)
- 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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe/Deep infiltrating endometriosis | – | Diagnostic Test: Blood biomarkersEndometriosis stage III/IV according to rASRM. |
| Minimal/mild endometriosis | – | Diagnostic Test: Blood biomarkersEndometriosis stage I/II according to rASRM |
| Controls | – | Diagnostic Test: Blood biomarkersWomen operated for other benign gynecological diseases and have no signs of endometriosis perioperatively. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- BMI> 40
- postmenopausal women
- premature ovarian failure
- pelvic inflammatory disease (PID)
- current or previous malignancy
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 |
|---|---|---|
| Blood biomarkersBlood biomarkers in plasma and serum. | Diagnostic test | Controls, Minimal/mild endometriosis, Severe/Deep infiltrating endometriosis |
Primary outcome
Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%
Time frame: Preoperative
Blood biomarkers as endometriosis diagnostic tests
Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis.
Time frame: 3-6 months postoperative in the severe/DIE group
Blood biomarkers as a relapse marker
Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%
Time frame: Preoperative
Blood biomarkers as endometriosis diagnostic tests
2 secondary outcomes
Quality of life of patients undergoing surgery for DIE
Time frame: Preoperative and 3-6 months postoperative in the severe/DIE group
Achieved pregnancy postoperative
Time frame: One year postoperative
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 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Kenny Rodriguez-Wallberg, Professor contact
Kenny Rodriguez-Wallberg, Professor principal investigator
Karolinska Institutet
3 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 Region Stockholm at 3 sites in Sweden.
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 0 inclusion and 10 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 Anastasia Drakou, MSc (0046 735500118, anastasia.drakou@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94% (time frame: Preoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.