Clinical Trial on Endometriosis - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Endometriosis

Detailed Description

Endometriosis (EM) is a common gynecological condition that occurs in women of reproductive age and is characterized by pain, masses, and infertility. EM is a tumor-like disease that is invasive, metastatic, recurrent, but the pathogenesis of EM has not yet been clarified. Advances in the study of intratumoral microbiota provided increasing evidence confirming the presence and mechanism of bacteria in tumor tissues. Therefore, the investigators wanted to investigate the correlation between endometriosis and its microbiota in the endometrial tissue.

Participants in this study will be recruited in the obstetrics and Obstetrics and Gynecology Medical Center of Zhujiang Hospital. With reference to the inclusion and exclusion criteria, patients admitted for surgery were under screening. Participants were assigned to Endometriosis group after confirmation by laparoscopy together with biopsy analysis, while the control group was identified as non-EM patients, usually with benign gynecologic conditions such as uterine fibroids or teratomas.

The investigators will obtain serum, vaginal swabs, cervical mucus, and feces from the participant before surgery. The peritoneal fluid, eutopic endometrium, and ectopic endometrium lesion will also be collected if the surgical approach allows. The specimens will be sent for microbiota sequencing, transcriptome sequencing, metabolome sequencing, single cell sequencing, and laboratory experiments.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ziwei Zhou, Dr
Phone Number: +8615626400134
Email: vivienchow@qq.com

Study Contact Backup

Name: Yuying Chen, Dr
Phone Number: +8618218058905
Email: 2265991412@qq.com

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China, 510280
    - Recruiting
    - Zhujiang Hospital
    - Contact:
      
      Ying Ma
      
      Phone Number: +8613113361169
      
      Email: mayingwuzhuoyi@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants in this study will be recruited in the obstetrics and Obstetrics and Gynecology Medical Center of Zhujiang Hospital. With reference to the inclusion and exclusion criteria, patients admitted for surgery were under screening.

Description

Inclusion Criteria:

Women aged 18-52 years old.
Regular menstruation with a cycle of 28-35 days.
No sexual intercourse 1 week before the operation.
No systemic or local use of antibiotics and probiotics for 6 months prior to surgery.
No history of acute or chronic pelvic inflammatory disease.
Subjects fully understand the significance of the study and sign the informed consent form.

Exclusion Criteria:

In pregnancy.
Intraoperative conditions or pathological examination suggest a malignant or junctional disease.
Severe anatomical abnormalities of the pelvis.
Pelvic contamination with large amounts of blood during laparoscopic operation.
History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation
Psychiatric, personality disorders, or abuse of psychoactive substances.
Immunodeficiencies, allergies, or autoimmune diseases.
Contraindications to endotracheal intubation anesthesia.
Absolute or relative contraindications to laparoscopic or hysteroscopic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EM group Patient diagnosed with endometriosis after confirmation by laparoscopic surgery and pathologic examination.
Control group Patient diagnosed without endometriosis after confirmation by laparoscopic surgery and pathologic examination, usually with benign gynecologic conditions such as uterine fibroids or teratomas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition Time Frame: 3 years	Using metagenomics sequencing of microbiota, compare the microbial composition differences of specimens derived from EM group and control group, including the alpha diversity(Shannon index, Simpson index, etc.), beta diversity(PCoA analysis, Bray-Curtis, etc.) differential taxonomy, and KEGG pathway prediction.	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

Principal Investigator: Ying Ma, PhD, Zhujiang Hospital, Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)