MicrobiotaMTBOD-1NCT03388996
Pelvic Microbiomes of Benign and Malignant Ovarian Diseases
An observational study of Microbiota and Ovarian Neoplasms, run by Lei Li at 1 site in China.
Trial summary
This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Microbiota, Ovarian Neoplasms, Ribosome Alteration
- What is being tested?
- microbiomes
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group of benign ovarian diseases: patients with definite benigh ovarian diseases or health conditions (eg infertlity) Group of malignant ovarian diseases: patients with definite diagnosis of high grade serous carcinoma
Who may be able to join
- Laparoscopy procedures
- Specific pathological diagnosis
Who cannot join
- Previous history of pelvic surgeries
- Evidences of pelvic inflammation diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: The Role of Pelvic Microbiomes During the Malignant Transformation of Benign Ovarian Diseases
This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures of laparoscopies. The discharges/flushing fluid would be sent for 16s RNA analysis and microculture respectively, and the results would get self-contrasted comparison and case-control comparison.
- Conditions
- Microbiota, Ovarian Neoplasms, Ribosome Alteration
- Being tested
- microbiomes
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiomesDiagnostic test
16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube
| Study group | Role | What they receive |
|---|---|---|
| Benign ovarian disease | The group consists of patients of benign ovarian diseases and health conditions (eg infertility), who would accept the tests of pelvic microbiomes. Receives: Diagnostic Test: microbiomes | |
| Malignant ovarian disease | The group consists of patients of high grade serous carcinoma, who would accept the tests of pelvic microbiomes. Receives: Diagnostic Test: microbiomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of species distribution of microorganism according to 16s RNA analysis
The difference of species of microorganism distribution according to 16s RNA sequencing analysis between control group and study group, and between different sampling sites in each arm
Measured: 2 years
Difference of species distribution of microorganism according to microculture outcomes
Difference of species distribution of microorganism according to microculture outcomes between control group and study group, and between different sampling sites in each arm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Collaborators
- Academy Military Medical Science, China
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388996
- Sponsor's protocol ID
- MTBOD-1
- Acronym
- MTBOD-1
- Status last verified
- Nov 2018
- First submitted
- 22 Dec 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We would share individual participant data to all other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pelvic Microbiomes During the Malignant Transformation of Benign Ovarian Diseases
- ClinicalTrials.gov ID
- NCT03388996
- Acronym / sponsor ID
- MTBOD-1 / MTBOD-1
- Conditions
- Microbiota, Ovarian Neoplasms, Ribosome Alteration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Collaborators
- Academy Military Medical Science, China
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 3 Jan 2018 (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.
This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures of laparoscopies. The discharges/flushing fluid would be sent for 16s RNA analysis and microculture respectively, and the results would get self-contrasted comparison and case-control comparison.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign ovarian disease | – | Diagnostic Test: microbiomesThe group consists of patients of benign ovarian diseases and health conditions (eg infertility), who would accept the tests of pelvic microbiomes. |
| Malignant ovarian disease | – | Diagnostic Test: microbiomesThe group consists of patients of high grade serous carcinoma, who would accept the tests of pelvic microbiomes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group of benign ovarian diseases: patients with definite benigh ovarian diseases or health conditions (eg infertlity) Group of malignant ovarian diseases: patients with definite diagnosis of high grade serous carcinoma
Key inclusion criteria (2 listed)
- Laparoscopy procedures
- Specific pathological diagnosis
Key exclusion criteria (2 listed)
- Previous history of pelvic surgeries
- Evidences of pelvic inflammation diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microbiomes16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube | Diagnostic test | Benign ovarian disease, Malignant ovarian disease |
Primary outcome
Difference of species distribution of microorganism according to 16s RNA analysis
Time frame: 2 years
The difference of species of microorganism distribution according to 16s RNA sequencing analysis between control group and study group, and between different sampling sites in each arm
Difference of species distribution of microorganism according to microculture outcomes
Time frame: 2 years
Difference of species distribution of microorganism according to microculture outcomes between control group and study group, and between different sampling sites in each arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Yes. We would share individual participant data to all other researchers
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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.
Lei Li, MD principal investigator
Peking Union Medical College Hospital
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 Microbiota and Ovarian Neoplasms, run by Lei Li 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 2 inclusion and 2 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 14 Nov 2018. 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 Lei Li, MD (008613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of species distribution of microorganism according to 16s RNA analysis (time frame: 2 years). The study lists 2 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 14 Nov 2018.