Endometrial CancerTJ IntrauterinNCT07048327
Cohort Study of Intrauterine Diseases
An observational study of Endometrial Cancer and Endometrial Hyperplasia, run by Wenwen Wang at 1 site in China.
Trial summary
"This study employs a prospective cohort design by establishing a uterine cavity diseases research platform. The investigators will collect participants' current medical history, menstrual and obstetric history, past medical history, physical and gynecological examinations, imaging studies, laboratory tests, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Hyperplasia, Endometrial Polyps
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study Population will be enrolled by a multicenter study led by Tongji Hospital , in collaboration with over 30 tertiary hospitals. Patients requiring hysteroscopic or curettage procedures for intrauterine lesions such as endometrial hyperplasia, polyps, and malignancies will be recruited.
Who may be able to join
- Age: 18-80 years;
- Patients requiring hysteroscopy or diagnostic curettage for intrauterine pathologies (e.g., endometrial hyperplasia, endometrial polyps, submucosal uterine fibroids, adenomyosis, or endometrial malignancies);
- Willing and able to comply with follow-up requirements;
- Signed informed consent obtained.
Who cannot join
- Concurrent participation in other drug clinical trials;
- Contraindications to or inability to tolerate hysteroscopy/curettage procedures;
- Unwilling or unable to provide informed consent;
- Unwilling or unable to adhere to study protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Pu Zhou, +86-027-83662379, tongjihlunli@163.com
Wen W Wang, Dr.
About this study
"This study employs a prospective cohort design by establishing a uterine cavity diseases research platform. The investigators will collect participants' current medical history, menstrual and obstetric history, past medical history, physical and gynecological examinations, imaging studies, laboratory tests, and pathological examinations. After the hysteroscopic surgery, the investigators will conduct a one-year follow-up on the disease progression of the participants. Through this comprehensive approach, the investigators aim to deeply investigate the pathogenesis, risk factors, and optimized treatment strategies for uterine cavity diseases."
Read the detailed description
Uterine cavity diseases are a common category of hormone-dependent gynecological conditions, encompassing a wide spectrum from benign lesions to malignant tumors, including endometrial hyperplasia, endometrial polyps, and endometrial malignancies.
Endometrial hyperplasia is classified into two types: hyperplasia without atypia and atypical hyperplasia. Atypical hyperplasia is considered a precancerous lesion of endometrial malignancies, which may lead to irregular vaginal bleeding, menstrual disorders, and carries the risk of malignant transformation. Endometrial polyps, a common benign lesion within the uterine cavity, often cause abnormal uterine bleeding, infertility, or recurrent miscarriages, significantly impacting women's reproductive health and quality of life. Endometrial malignancies, the most prevalent malignant tumors in the female reproductive system, pose a serious threat to women's lives and safety. These diseases not only profoundly affect women's physical health but also have far-reaching negative consequences on their mental well-being, social functioning, and overall quality of life.
In light of this, this study aims to utilize patients' clinical data resources to establish a cohort research platform for uterine cavity diseases, bridging the gap between clinical practice and scientific research, and providing valuable clinical data resources for in-depth studies on these conditions.
- Being tested
- No intervention (observational study)
- Keywords
- Intrauterine diseases, Endometrial Cancer, Endometrial Hyperplasia, Endometrial Polyps, Cohort Study
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine Diseases Cohort | Disease-specific cohort for uterine cavity diseases Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence of endometrial polyps or endometrial hyperplasia.
To evaluate the presence of disease progression and recurrence through imaging results.
Measured: Follow up every three months for one year after hysteroscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenwen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenwen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048327
- Sponsor's protocol ID
- CSID
- Acronym
- TJ Intrauterin
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared due to ethical restrictions and participant privacy protections outlined in the informed consent documents.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Intrauterine Diseases
- ClinicalTrials.gov ID
- NCT07048327
- Acronym / sponsor ID
- TJ Intrauterin / CSID
- Keywords
- Intrauterine diseases, Endometrial Cancer, Endometrial Hyperplasia, Endometrial Polyps, Cohort Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Wenwen WangUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 Jul 2025 (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 employs a prospective cohort design by establishing a uterine cavity diseases research platform. The investigators will collect participants' current medical history, menstrual and obstetric history, past medical history, physical and gynecological examinations, imaging studies, laboratory tests, and pathological examinations. After the hysteroscopic surgery, the investigators will conduct a one-year follow-up on the disease progression of the participants. Through this comprehensive approach, the investigators aim to deeply investigate the pathogenesis, risk factors, and optimized treatment strategies for uterine cavity diseases."
Detailed description
Uterine cavity diseases are a common category of hormone-dependent gynecological conditions, encompassing a wide spectrum from benign lesions to malignant tumors, including endometrial hyperplasia, endometrial polyps, and endometrial malignancies.
Endometrial hyperplasia is classified into two types: hyperplasia without atypia and atypical hyperplasia. Atypical hyperplasia is considered a precancerous lesion of endometrial malignancies, which may lead to irregular vaginal bleeding, menstrual disorders, and carries the risk of malignant transformation. Endometrial polyps, a common benign lesion within the uterine cavity, often cause abnormal uterine bleeding, infertility, or recurrent miscarriages, significantly impacting women's reproductive health and quality of life. Endometrial malignancies, the most prevalent malignant tumors in the female reproductive system, pose a serious threat to women's lives and safety. These diseases not only profoundly affect women's physical health but also have far-reaching negative consequences on their mental well-being, social functioning, and overall quality of life.
In light of this, this study aims to utilize patients' clinical data resources to establish a cohort research platform for uterine cavity diseases, bridging the gap between clinical practice and scientific research, and providing valuable clinical data resources for in-depth studies on these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrauterine Diseases Cohort | – | Other: No intervention (observational study)Disease-specific cohort for uterine cavity diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population will be enrolled by a multicenter study led by Tongji Hospital , in collaboration with over 30 tertiary hospitals. Patients requiring hysteroscopic or curettage procedures for intrauterine lesions such as endometrial hyperplasia, polyps, and malignancies will be recruited.
Key inclusion criteria (4 listed)
- Age: 18-80 years;
- Patients requiring hysteroscopy or diagnostic curettage for intrauterine pathologies (e.g., endometrial hyperplasia, endometrial polyps, submucosal uterine fibroids, adenomyosis, or endometrial malignancies);
- Willing and able to comply with follow-up requirements;
- Signed informed consent obtained.
Key exclusion criteria (4 listed)
- Concurrent participation in other drug clinical trials;
- Contraindications to or inability to tolerate hysteroscopy/curettage procedures;
- Unwilling or unable to provide informed consent;
- Unwilling or unable to adhere to study protocols.
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 |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Intrauterine Diseases Cohort |
Primary outcome
The recurrence of endometrial polyps or endometrial hyperplasia.
Time frame: Follow up every three months for one year after hysteroscopic surgery
To evaluate the presence of disease progression and recurrence through imaging results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared due to ethical restrictions and participant privacy protections outlined in the informed consent documents.
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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.
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 Endometrial Cancer and Endometrial Hyperplasia, run by Wenwen Wang 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 4 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen W Wang, Dr. (+86 15927167698, petrawang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence of endometrial polyps or endometrial hyperplasia. (time frame: Follow up every three months for one year after hysteroscopic surgery). 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 2 Jul 2025.