Biomarkers for Endometriosis

ConditionEndometriosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-45

SponsorTrio Fertility

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women of reproductive age group (18Y-45Y).

Women with active endometriosis diagnosed by ultrasound/MRI/laparoscopy.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.
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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Endometriosis Group2 interventions

Group B: Control Group2 interventions

Trial outcomes

Primary outcomes

Synuclein Gamma (SNCG) and B-cell Lymphoma 6 (BCL-6) Levels

Synuclein Gamma (SNCG) and B-cell Lymphoma 6 (BCL-6) 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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trio Fertility

Lead sponsor

Source ClinicalTrials.gov

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