AdenomyosisNCT04010487
Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
An observational study of Adenomyosis and Endometrial Cancer, run by Lei Li at 1 site in China.
Trial summary
This study is to explore the driving genes and the molecular mechanism of malignant transformation of adenomyosis. This study acquired the formalin fixed paraffin-embedded (FFPE) tissue of patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) treated at Peking Union Medical College… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenomyosis, Endometrial Cancer, Ectopic Endometrial Tissue
- What is being tested?
- whole exome sequencing and RNA-sequencing
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2019to 1 Aug 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes two groups patients (about 22 cases in each group): * Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) * Patients pathologically diagnosed with adenomyosis
Who may be able to join
- Pathological confirmed diagnosis with atypical hyperplasia and malignant transformation of adenomyosis glandular epithelium (including endometrioid, serous and clear cell carcinoma), with or without concurrent endometrial carcinoma
- Signed an approved informed consents
Who cannot join
- Not meeting all the inclusion criteria.
- The formalin fixed paraffin-embedded (FFPE) tissue was not acquired at the required time period.
- The patients enrolled had accompanied some other kinds of carcinoma (such as ovarian cancer, cervical cancer, primary peritoneal cancer).
- Patients had cancer history of certain organ (such as colorectal cancer, gastric cancer, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: A Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
This study is to explore the driving genes and the molecular mechanism of malignant transformation of adenomyosis. This study acquired the formalin fixed paraffin-embedded (FFPE) tissue of patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) treated at Peking Union Medical College Hospital from July 15, 2017 to July 15, 2019. The formalin fixed paraffin-embedded tissues from patients pathologically diagnosed with adenomyosis during this time period were also included as control specimens. The eutopic endometrium, normal adenomyosis tissue, and EC-AIA tissue were harvested from the FFPE tissue from patients with EC-AIA. The normal eutopic endometrium and normal adenomyosis tissue were obtained by laser microdissection. The driving genes and potential molecular mechanism of EC-AIA will be found by the technology of whole exome sequencing and transcriptomics (RNA-sequencing).
- Conditions
- Adenomyosis, Endometrial Cancer, Ectopic Endometrial Tissue, Eutopic Endometrium, Genomics, Transcriptomics
- Being tested
- whole exome sequencing and RNA-sequencing
- Medical subject headings
- Adenomyosis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole exome sequencing and RNA-sequencingGenetic
The specimens from adenomyosis, endometrial cancer, and eutopic endometrium will be tested by whole exome sequencing and RNA-sequencing
| Study group | Role | What they receive |
|---|---|---|
| Endometrial carcinoma arising in adenomyosis | Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) Receives: Genetic: whole exome sequencing and RNA-sequencing | |
| Adenomyosis without malignancy | Patients pathologically diagnosed with adenomyosis Receives: Genetic: whole exome sequencing and RNA-sequencing |
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 ectopic endometrium, and cancer tissues by whole exome sequencing
Measured: One year
Frequencies of alteration of RNA expression
The alteration of RNA expression, including mRNA, miRNA, and lncRNA will be compared between eutopic and ectopic endometrium, and cancer tissues by transcriptome sequencing
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start16 Jul 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (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
- Retrospective
- Enrolment
- 40 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
- NCT04010487
- Sponsor's protocol ID
- AM-OMICS2
- Status last verified
- Jul 2019
- First submitted
- 3 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
- ClinicalTrials.gov ID
- NCT04010487
- Acronym / sponsor ID
- AM-OMICS2
- Conditions
- Adenomyosis, Endometrial Cancer, Ectopic Endometrial Tissue, Eutopic Endometrium, Genomics, Transcriptomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 8 Jul 2019 (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 is to explore the driving genes and the molecular mechanism of malignant transformation of adenomyosis. This study acquired the formalin fixed paraffin-embedded (FFPE) tissue of patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) treated at Peking Union Medical College Hospital from July 15, 2017 to July 15, 2019. The formalin fixed paraffin-embedded tissues from patients pathologically diagnosed with adenomyosis during this time period were also included as control specimens. The eutopic endometrium, normal adenomyosis tissue, and EC-AIA tissue were harvested from the FFPE tissue from patients with EC-AIA. The normal eutopic endometrium and normal adenomyosis tissue were obtained by laser microdissection. The driving genes and potential molecular mechanism of EC-AIA will be found by the technology of whole exome sequencing and transcriptomics (RNA-sequencing).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial carcinoma arising in adenomyosis | – | Genetic: whole exome sequencing and RNA-sequencingPatients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) |
| Adenomyosis without malignancy | – | Genetic: whole exome sequencing and RNA-sequencingPatients pathologically diagnosed with adenomyosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes two groups patients (about 22 cases in each group): * Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) * Patients pathologically diagnosed with adenomyosis
Key inclusion criteria (2 listed)
- Pathological confirmed diagnosis with atypical hyperplasia and malignant transformation of adenomyosis glandular epithelium (including endometrioid, serous and clear cell carcinoma), with or without concurrent endometrial carcinoma
- Signed an approved informed consents
Key exclusion criteria (4 listed)
- Not meeting all the inclusion criteria.
- The formalin fixed paraffin-embedded (FFPE) tissue was not acquired at the required time period.
- The patients enrolled had accompanied some other kinds of carcinoma (such as ovarian cancer, cervical cancer, primary peritoneal cancer).
- Patients had cancer history of certain organ (such as colorectal cancer, gastric cancer, etc.)
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 |
|---|---|---|
| whole exome sequencing and RNA-sequencingThe specimens from adenomyosis, endometrial cancer, and eutopic endometrium will be tested by whole exome sequencing and RNA-sequencing | Genetic | Adenomyosis without malignancy, Endometrial carcinoma arising in adenomyosis |
Primary outcome
Frequencies of somatic driving mutations
Time frame: One year
The differences of distributions and frequencies of somatic driving mutations will be compared between eutopic ectopic endometrium, and cancer tissues by whole exome sequencing
Frequencies of alteration of RNA expression
Time frame: One year
The alteration of RNA expression, including mRNA, miRNA, and lncRNA will be compared between eutopic and ectopic endometrium, and cancer tissues by transcriptome sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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 Endometrial Cancer, 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 4 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 18 Jul 2019. 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. (+8613911988831, 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: One year). 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 18 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.