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NCT Number: NCT05339451

Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska Universitetssjukhus Huddinge, Stockholm, Huddinge, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

IInclusion Criteria:

  • women of reproductive age (18-45) who are operated because of suspected endometriosis (dysmenorrhea, dyspareunia, infertility, etc.) (patient group)
  • women of reproductive age (18-45) who are operated for other benign gynecological causes with laparoscopy (ovarian cysts, sterilization, fibroids, etc.) and are found without macroscopic endometriosis perioperatively and confirmed with blind biopsies (control group
  • talk swedish or english in order to complete questionnaires and give informed consent for their participation in the study.

Exclusion criteria

  • BMI> 40
  • postmenopausal women
  • premature ovarian failure
  • pelvic inflammatory disease (PID)
  • current or previous malignancy
  • pregnancy and 6 months postpartum
  • corticosteroids in the last 3 months
  • pituitary, kidney, liver, adrenal disease
  • endometrial hyperplasia or endometrial polyp
  • cardiovascular or systemic inflammatory diseases.

Treatment and study plan

Blood Biomarkers

Diagnostic Test

Blood biomarkers in plasma and serum.

Primary outcomes

  1. Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94%

    Time frame: Preoperative

    Blood biomarkers as endometriosis diagnostic tests

  2. 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

  3. Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79%

    Time frame: Preoperative

    Blood biomarkers as endometriosis diagnostic tests

Secondary outcomes

  1. Quality of life of patients undergoing surgery for DIE

    Time frame: Preoperative and 3-6 months postoperative in the severe/DIE group

    Endometriosis Health Profile 30 Questionnaire

  2. Achieved pregnancy postoperative

    Time frame: One year postoperative

    Positive pregnancy test

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasia Drakou, MSc

CONTACT

[email protected]

0046 735500118

Kenny Rodriguez-Wallberg, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet
  • Stockholm South General Hospital
  • Uppsala University Hospital

Registry information

Official study title

Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)

Acronym: ENDOBIO

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 21, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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