NCT07048327

Brief 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 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."

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jul 2025Jul 2028

First Submitted

Initial submission to the registry

June 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

June 19, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

Intrauterine diseasesEndometrial CancerEndometrial HyperplasiaEndometrial PolypsCohort Study

Outcome Measures

Primary Outcomes (1)

  • The recurrence of endometrial polyps or endometrial hyperplasia.

    To evaluate the presence of disease progression and recurrence through imaging results.

    Follow up every three months for one year after hysteroscopic surgery

Study Arms (1)

Intrauterine Diseases Cohort

Disease-specific cohort for uterine cavity diseases

Other: No intervention (observational study)

Interventions

No intervention (observational study)

Intrauterine Diseases Cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsEndometrial Hyperplasia

Interventions

Observation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Wen W Wang, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 19, 2025

First Posted

July 2, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data cannot be shared due to ethical restrictions and participant privacy protections outlined in the informed consent documents.

Locations