Atypical Endometrial Hyperplasia and Endometrial CancerNCT06170684
Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer
An observational study of Atypical Endometrial Hyperplasia and Endometrial Cancer, run by Beijing Obstetrics and Gynecology Hospital.
Trial summary
Exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. Study the factors related to predicting treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Atypical Endometrial Hyperplasia and Endometrial Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jan 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with atypical endometrial hyperplasia and endometrial cancer who received conservative treatment
Who may be able to join
- (1) age ≤ 45 years old, strong desire to preserve reproductive function, and no factors of reproductive dysfunction evaluated before treatment; (2) The pathological type is atypical endometrial hyperplasia or endometrial cancer; (3) Imaging examination confirmed that the tumor was localized to the endometrium; (4) There are follow-up conditions available.
Who cannot join
None listed.
About this study
Official title: Clinical Study of Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer
Exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. Study the factors related to predicting treatment efficacy.
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
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 |
|---|---|---|
| complete remission | Not described | |
| non-complete remission | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Endometrial Hyperplasia and Endometrial CancerStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Obstetrics and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyan Ren, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170684
- Sponsor's protocol ID
- BeijingOGh，
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06170684
- Acronym / sponsor ID
- BeijingOGh，
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Obstetrics and Gynecology HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 14 Dec 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.
Exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. Study the factors related to predicting treatment efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete remission | – | – |
| non-complete remission | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with atypical endometrial hyperplasia and endometrial cancer who received conservative treatment
Key inclusion criteria (1 listed)
- (1) age ≤ 45 years old, strong desire to preserve reproductive function, and no factors of reproductive dysfunction evaluated before treatment; (2) The pathological type is atypical endometrial hyperplasia or endometrial cancer; (3) Imaging examination confirmed that the tumor was localized to the endometrium; (4) There are follow-up conditions available.
Key exclusion criteria (0 listed)
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
Complete remission rate
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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.
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 Atypical Endometrial Hyperplasia and Endometrial Cancer, run by Beijing Obstetrics and Gynecology 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 1 inclusion and 0 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 Dec 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?
Complete remission rate (time frame: 6months). 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 Dec 2023.