Omics Sequencing of Specimen Derived From Patients With Endometriosis

Sponsor
Zhujiang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05086484
Collaborator
(none)
1,000
1
84
11.9

Study Details

Study Description

Brief Summary

Endometriosis is a type of chronic inflammatory gynecological disease, mainly took place in peritoneal cavity. In order to investigate the possible correlation between microbes and endometriosis, the investigators planed to perform 16S rDNA amplicon sequencing, metagenomic sequencing and metabolomic sequencing of paired samples derived from feces, cervical mucus, blood and peritoneal fluid.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Omics Sequencing of Specimen Derived From Patients With Endometriosis
    Actual Study Start Date :
    Jan 1, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Endometriosis group

    Women diagnosed with endometriosis.

    Control group

    Women diagnosed without endometriosis.

    Outcome Measures

    Primary Outcome Measures

    1. 16s amplicon sequencing [2019/01/01-2023/12/31]

      Compare the microbiota composition differences of specimens derived from control group and Endometriosis group.

    2. metatranscriptomic sequencing [2019/01/01-2023/12/31]

      Compare the RNA concentration differences of specimens derived from control group and Endometriosis group.

    3. metabolomic sequencing [2019/01/01-2023/12/31]

      Compare the metabolites concentration differences of specimens derived from control group and Endometriosis group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 52 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. The subject who is female.

    2. The subject who is infertility or sub-fertile.

    3. The subject whose age was between 18-52 years old.

    4. The subject who is suspected to have endometrioma.

    5. The subject whose menstrual cycle length is between 28-35 days.

    6. The subject without the history of abdominal or pelvic surgery.

    7. The subject who has dysmenorrhea.

    8. The subject who has dispareunia.

    9. The subject who was informed the risks and benefits of the experiment and provided written informed consent, and gave their approval.

    10. The subject who has chronic pelvic pain and the pain get worse during periods.

    11. The subject who has no sexual activity within a week.

    12. The subject who has no history of acute or chronic pelvic inflammatory disease.

    13. The subject who has confirmed EM with biopsy.

    14. The subject without hormonotherapy within 6 months.

    15. The subject without medical history of antibiotics within 6 months.

    Exclusion Criteria:
    1. The subject who has hernia.

    2. The subject who is pregnant.

    3. The subject who has malignant tumor.

    4. The subject who has Gene Therapy history.

    5. The subject who has abdominal or pelvic surgery history.

    6. The subject who has peritonitis.

    7. The subject who is below 18 years old or over 52 years old.

    8. The subject who can not endure laparoscopy.

    9. The subject who has cardiovascular disease.

    10. The subject who has systemic or regional acute inflammation.

    11. The subject who has chronic liver or kidney disease.

    12. The subject whoes body mass index ≤ 18.5 or ≥ 28 (kg m-2).

    13. The subject who has coagulation defects or hematologic diseases.

    14. The subject who has tuberculosis or chronic obstructive pulmonary disease.

    15. The subject whoes alcohol consumption ≥ 60 g d-1, or smokers (≥20 cigarettes d-1).

    16. The subject who has hypertension, diabetes, hyperthyroidism and ect.

    17. The subject whoes medical history of transfusion, stem cell or bone marrow transplantation.

    18. The subject who has contraindication of tracheal intubation anesthesia.

    19. The subject who received hormonotherapy within 6 months.

    20. The subject who has immunodeficient, allergic or autoimmune diseases.

    21. The subject who used antibiotics within 6 months.

    22. The subject who is drug abuse.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhujiang Hospital Guangzhou Guangdong China

    Sponsors and Collaborators

    • Zhujiang Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhujiang Hospital
    ClinicalTrials.gov Identifier:
    NCT05086484
    Other Study ID Numbers:
    • ZhujiangHfck
    First Posted:
    Oct 21, 2021
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhujiang Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 21, 2021