Biomarkers for Endometriosis

NCT07713797 | Recruiting

• 1 other identifier: ENDOID/001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a condition in which tissue similar to the lining of the uterus grows outside the uterus, often causing pain and infertility. Currently, endometriosis can only be definitively diagnosed through invasive procedures like laparoscopy and biopsy. The purpose of this study is to investigate whether the proteins Synuclein Gamma (SNCG) and B-Cell Lymphoma 6 (BCL6), measurable in blood and menstrual fluid, can serve as non-invasive biomarkers to diagnose or monitor endometriosis.

Conditions

Endometriosis

Keywords

endometriosis; biomarkers; BCL6; SNCG

Outcome Measures

Primary Outcomes (1)

• SNCG and BCL-6 Levels

  SNCG and BCL6 levels (ng/ml) in serum/menstrual supernatant will be quantitated using specific ELISA kits and will be compared for significant differences in patients with endometriosis from control subjects as well as their changes before and after the treatment in endometriosis group.

  Baseline for control participants and baseline and approximately 3 months after treatment for participants with endometriosis

Study Arms (2)

Endometriosis Group

Patients who have been diagnosed with Endometriosis

Diagnostic Test: SNCG Protein; Diagnostic Test: BCL-6 Protein

Control Group

Patients who have not been diagnosed with Endometriosis

Diagnostic Test: SNCG Protein; Diagnostic Test: BCL-6 Protein

Interventions

SNCG Protein DIAGNOSTIC_TEST

Synuclein gamma (SNCG), a member of the synuclein family of neuronal proteins, is involved in cellular proliferation by interacting with the mitotic checkpoint kinase BubR1, and inhibiting its regulatory role on cellular proliferation. During the last decade, several studies have demonstrated that SNCG is correlated with poor outcome of breast cancer, ovarian cancer, colon cancer and pancreatic cancer. Interestingly, SNCG has previously been shown to have elevated expression ranging from 5- to 53-fold in ovarian endothelial cells of endometriosis lesions compared with eutopic endometrium from the same individual.

Control Group; Endometriosis Group

BCL-6 Protein DIAGNOSTIC_TEST

B-Cell Lymphoma 6 (BCL6) protein is encoded by the BCL6 oncogene and is a zinc finger transcription factor that regulates the transcription of signal transducer and activators of transcription (STAT)-dependent IL-4 responses of B-cells. Previously, BCL6 was shown to express in the endometrial epithelial cells and B-cells in lymph node germinal centers. In addition, over-expression of BCL6 has been reported in endometrial biopsies and has been linked to the progesterone resistance and pathogenesis of endometriosis

Control Group; Endometriosis Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only people who have female reproductive system
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will focus on measuring circulatory SNCG and BCL6 concentrations in patients with endometriosis compared to age-matched healthy subjects without endometriosis. Patients with confirmed endometriosis, and the healthy control group will be recruited at TRIO Fertility following informed consent.

You may qualify if:

• Women of reproductive age group (18Y-45Y).
• Women with active endometriosis diagnosed by ultrasound/MRI/laparoscopy.

You may not qualify if:

• Women \<18Y and \>45Y.
• Women with endometriosis during stimulation with gonadotropins.
• Current or prior history of uterine, ovarian, colon, pancreatic, breast or any other type of cancer.
• Any prior history of chronic illness.
• Pregnant women.
• Women of reproductive age group (18Y-45Y).
• Women without endometriosis and any other gynaecological problem.
• Women \<18Y and \>45Y
• Prior history of any disease including cancer or chronic illness.
• Pregnant women.

Sponsors & Collaborators

• Trio Fertility: lead

Study Sites (1)

Trio Fertility

Toronto, Ontario, M5G 2K4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Peripheral Blood Sample: 10 mL of blood will be collected from a vein in the arm using a sterile needle and collection vial (VACUTAINER). 2. Menstrual Blood Sample: Using a provided reusable menstrual cup (DIVA), they will collect approximately 5 mL of menstrual blood on the 1st or 2nd day of their menstrual cycle. Menstrual blood will be processed to separate supernatant and stored in 1 mL aliquots at -80°C until analysis. 3. Follow-up Samples for Endometriosis Group: If they are in the endometriosis group and undergo treatment (medical or surgical), additional blood and menstrual samples will be collected at 3 months and 6 months post-treatment to assess changes in SNCG and BCL6 levels.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yasaman Sadeghi, M.Sc.

CONTACT

4165060804; yasamans@triofertility.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 20, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CA (1)