EndometriosisNCT05086484
Omics Sequencing of Specimen Derived From Patients With Endometriosis
An observational study of Endometriosis, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study population are those who are admitted to Zhujiang Hospital of Southern Medical University in Guangzhou, China, due to gynecological diseases. At least two gynecologists independently screened and assessed the condition of the participants strictly according to the inclusion and exclusion criteria
Who may be able to join
- The subject who is female.
- The subject who is infertility or sub-fertile.
- The subject whose age was between 18-52 years old.
- The subject who is suspected to have endometrioma.
- The subject whose menstrual cycle length is between 28-35 days.
- The subject without the history of abdominal or pelvic surgery.
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- The subject who has dysmenorrhea.
- The subject who has dispareunia.
- The subject who was informed the risks and benefits of the experiment and provided written informed consent, and gave their approval.
- The subject who has chronic pelvic pain and the pain get worse during periods.
- The subject who has no sexual activity within a week.
- The subject who has no history of acute or chronic pelvic inflammatory disease.
- The subject who has confirmed EM with biopsy.
- The subject without hormonotherapy within 6 months.
- The subject without medical history of antibiotics within 6 months.
Who cannot join
- The subject who has hernia.
- The subject who is pregnant.
- The subject who has malignant tumor.
- The subject who has Gene Therapy history.
- The subject who has abdominal or pelvic surgery history.
- The subject who has peritonitis.
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- The subject who is below 18 years old or over 52 years old.
- The subject who can not endure laparoscopy.
- The subject who has cardiovascular disease.
- The subject who has systemic or regional acute inflammation.
- The subject who has chronic liver or kidney disease.
- The subject whoes body mass index ≤ 18.5 or ≥ 28 (kg m-2).
- The subject who has coagulation defects or hematologic diseases.
- The subject who has tuberculosis or chronic obstructive pulmonary disease.
- The subject whoes alcohol consumption ≥ 60 g d-1, or smokers (≥20 cigarettes d-1).
- The subject who has hypertension, diabetes, hyperthyroidism and ect.
- The subject whoes medical history of transfusion, stem cell or bone marrow transplantation.
- The subject who has contraindication of tracheal intubation anesthesia.
- The subject who received hormonotherapy within 6 months.
- The subject who has immunodeficient, allergic or autoimmune diseases.
- The subject who used antibiotics within 6 months.
- The subject who is drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong
Ying Ma, PhD, 13113361169, mayingwuzhuoyi@126.com
Liujing Huang, Bachelor, 15916388839, 15916388839@163.com
About this study
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.
- Conditions
- Endometriosis
- Keywords
- Endometriosis, microbiota, metabolomic
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis group | Women diagnosed with endometriosis. | |
| Control group | Women diagnosed without endometriosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
16s amplicon sequencing
Compare the microbiota composition differences of specimens derived from control group and Endometriosis group.
Measured: 2019/01/01-2023/12/31
metatranscriptomic sequencing
Compare the RNA concentration differences of specimens derived from control group and Endometriosis group.
Measured: 2019/01/01-2023/12/31
metabolomic sequencing
Compare the metabolites concentration differences of specimens derived from control group and Endometriosis group.
Measured: 2019/01/01-2023/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086484
- Sponsor's protocol ID
- ZhujiangHfck
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omics Sequencing of Specimen Derived From Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT05086484
- Acronym / sponsor ID
- ZhujiangHfck
- Conditions
- Endometriosis
- Keywords
- Endometriosis, microbiota, metabolomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis group | – | –Women diagnosed with endometriosis. |
| Control group | – | –Women diagnosed without endometriosis. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population are those who are admitted to Zhujiang Hospital of Southern Medical University in Guangzhou, China, due to gynecological diseases. At least two gynecologists independently screened and assessed the condition of the participants strictly according to the inclusion and exclusion criteria
Key inclusion criteria (15 listed)
- The subject who is female.
- The subject who is infertility or sub-fertile.
- The subject whose age was between 18-52 years old.
- The subject who is suspected to have endometrioma.
- The subject whose menstrual cycle length is between 28-35 days.
Key exclusion criteria (22 listed)
- The subject who has hernia.
- The subject who is pregnant.
- The subject who has malignant tumor.
- The subject who has Gene Therapy history.
- The subject who has abdominal or pelvic surgery history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
16s amplicon sequencing
Time frame: 2019/01/01-2023/12/31
Compare the microbiota composition differences of specimens derived from control group and Endometriosis group.
metatranscriptomic sequencing
Time frame: 2019/01/01-2023/12/31
Compare the RNA concentration differences of specimens derived from control group and Endometriosis group.
metabolomic sequencing
Time frame: 2019/01/01-2023/12/31
Compare the metabolites concentration differences of specimens derived from control group and Endometriosis group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Ma, PhD (13113361169, mayingwuzhuoyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16s amplicon sequencing (time frame: 2019/01/01-2023/12/31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.