the Dynamic Evolution of Endometrial CarcinogenesisNCT06007300
A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis
An observational study of the Dynamic Evolution of Endometrial Carcinogenesis and Multiomics Analysis, run by RenJi Hospital.
Trial summary
The goal of this observational study is to draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients with atypical endometrial hyperplasia, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- the Dynamic Evolution of Endometrial Carcinogenesis, Multiomics Analysis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jun 2026
- 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: Patients with normal endometrium (requiring diagnostic or therapeutic hysteroscopy or hysterectomy for other reasons), patients with precancerous lesions of endometrium, and patients with endometrial cancer who underwent surgery in the gynecology and obstetrics department of Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, whose illness was diagnosed as normal endometrium, atypical hyperplasia endometrium, or endometrial cancer by pathology.
Who may be able to join
- Pathological diagnosis: normal endometrium, atypical hyperplasia endometrium, or endometrial cancer;
- Obtain pathological results after undergoing hysteroscopic surgery or hysterectomy;
- The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements;
- Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.
Who cannot join
- Patients with malignant tumors in other parts of the body;
- Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders;
- Poor compliance and inability to cooperate and describe treatment responders.
About this study
The goal of this observational study is to draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to explore the underlying molecular mechanism, and establish the database system for the dynamic evolution of endometrial carcinogenesis.
- Keywords
- Dynamic Evolution, Genomics, Transcriptome, Proteomics, Metabolomics
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 |
|---|---|---|
| Normal Group | Patients with normal endometrium | |
| Precancerous Group | Patients with atypical hyperplasia of endometrium | |
| Carcinoma Group | Patients with endometrial cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis
Measured: August 2023 to June 2026
Differences in the expression of these mutant genes among the three groups of participants as assessed by SAS® 9.4
Measured: January 2026 to June 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Dynamic Evolution of Endometrial CarcinogenesisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007300
- Sponsor's protocol ID
- LY-2023-136-B
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis
- ClinicalTrials.gov ID
- NCT06007300
- Acronym / sponsor ID
- LY-2023-136-B
- Keywords
- Dynamic Evolution, Genomics, Transcriptome, Proteomics, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Aug 2023 (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.
The goal of this observational study is to draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to explore the underlying molecular mechanism, and establish the database system for the dynamic evolution of endometrial carcinogenesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Group | – | –Patients with normal endometrium |
| Precancerous Group | – | –Patients with atypical hyperplasia of endometrium |
| Carcinoma Group | – | –Patients with endometrial cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with normal endometrium (requiring diagnostic or therapeutic hysteroscopy or hysterectomy for other reasons), patients with precancerous lesions of endometrium, and patients with endometrial cancer who underwent surgery in the gynecology and obstetrics department of Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, whose illness was diagnosed as normal endometrium, atypical hyperplasia endometrium, or endometrial cancer by pathology.
Key inclusion criteria (4 listed)
- Pathological diagnosis: normal endometrium, atypical hyperplasia endometrium, or endometrial cancer;
- Obtain pathological results after undergoing hysteroscopic surgery or hysterectomy;
- The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements;
- Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.
Key exclusion criteria (3 listed)
- Patients with malignant tumors in other parts of the body;
- Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders;
- Poor compliance and inability to cooperate and describe treatment responders.
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
The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis
Time frame: August 2023 to June 2026
Differences in the expression of these mutant genes among the three groups of participants as assessed by SAS® 9.4
Time frame: January 2026 to June 2026
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of the Dynamic Evolution of Endometrial Carcinogenesis and Multiomics Analysis, run by RenJi Hospital.
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 4 inclusion and 3 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis (time frame: August 2023 to June 2026). 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 23 Aug 2023.