AdenomyosisNCT03742843
A Multi-omics Study of Adenomyosis
An observational study of Adenomyosis and Endometriosis, run by Lei Li at 1 site in China.
Trial summary
This study aims to analyze the multi-omics results between eutopic endometrium, adenomyosis and endometriosis of patients diagnosed of adenomyosis with and without endometriosis. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenomyosis, Endometriosis, Ectopic Endometrium
- What is being tested?
- A multi-omics analysis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 23 Nov 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with adenomyosis and/or endomtriosis and feasible for biopsy will be included.
Who may be able to join
- Confirmed adenomyosis and/or endometriosis
- Signed an approved informed consents
- Feasible for biopsy
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 13911988831 ext. 86, lileigh@163.com
About this study
Official title: A Multi-omics Study on the Tumorigenesis of Adenomyosis
This study aims to analyze the multi-omics results between eutopic endometrium, adenomyosis and endometriosis of patients diagnosed of adenomyosis with and without endometriosis. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the pathogenesis of adenomyosis.
- Conditions
- Adenomyosis, Endometriosis, Ectopic Endometrium, Eutopic Endometrium, Genomics, Transcriptomics
- Being tested
- A multi-omics analysis
- Medical subject headings
- Adenomyosis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multi-omics analysisCombination product
A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium
| Study group | Role | What they receive |
|---|---|---|
| Group of adenomyosis | Patients with adenomyosis with or without endometriosis Receives: Combination Product: A multi-omics analysis | |
| Group of endometriosis | Patients with endometriosis without adenomyosis Receives: Combination Product: A multi-omics analysis | |
| Group of control | Patients without adenomyosis or endometriosis Receives: Combination Product: A multi-omics analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of somatic driving mutations
The differences of distributions and frequencies of somatic driving mutations will be compared between eutopic endometrium and ectopic endometrium by whole exome sequencing.
Measured: Two years
Secondary outcomes (3)
Frequencies of alteration of RNA expression
The alteration of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between eutopic endometrium and ectopic endometrium by transcriptome sequencing.
Measured: Two years
Frequencies of alteration of protein expression and signal pathway
The alteration of protein expression and signal pathway will be compared between eutopic endometrium and ectopic endometrium by metabolomic sequencing
Measured: Two years
Progression-free survival
Progression-free survival between patients with differential expressed multi-omics will be compared.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start10 Nov 2018
- Primary completion23 Nov 2020 (estimated)
- Study completion23 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742843
- Sponsor's protocol ID
- AM-OMICS
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Study on the Tumorigenesis of Adenomyosis
- ClinicalTrials.gov ID
- NCT03742843
- Acronym / sponsor ID
- AM-OMICS
- Conditions
- Adenomyosis, Endometriosis, Ectopic Endometrium, Eutopic Endometrium, Genomics, Transcriptomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 23 Nov 2020 (estimated)
- Study completion
- 23 Nov 2020 (estimated)
- First posted
- 15 Nov 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 study aims to analyze the multi-omics results between eutopic endometrium, adenomyosis and endometriosis of patients diagnosed of adenomyosis with and without endometriosis. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the pathogenesis of adenomyosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group of adenomyosis | – | Combination Product: A multi-omics analysisPatients with adenomyosis with or without endometriosis |
| Group of endometriosis | – | Combination Product: A multi-omics analysisPatients with endometriosis without adenomyosis |
| Group of control | – | Combination Product: A multi-omics analysisPatients without adenomyosis or endometriosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with adenomyosis and/or endomtriosis and feasible for biopsy will be included.
Key inclusion criteria (3 listed)
- Confirmed adenomyosis and/or endometriosis
- Signed an approved informed consents
- Feasible for biopsy
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| A multi-omics analysisA multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium | Combination product | Group of adenomyosis, Group of control, Group of endometriosis |
Primary outcome
Frequencies of somatic driving mutations
Time frame: Two years
The differences of distributions and frequencies of somatic driving mutations will be compared between eutopic endometrium and ectopic endometrium by whole exome sequencing.
3 secondary outcomes
Frequencies of alteration of RNA expression
Time frame: Two years
Frequencies of alteration of protein expression and signal pathway
Time frame: Two years
Progression-free survival
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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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, M.D. 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 Adenomyosis and Endometriosis, 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 3 inclusion and 1 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 15 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, M.D. (13911988831 ext. 86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of somatic driving mutations (time frame: Two years). 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 15 Nov 2018.