NCT06745427

Brief Summary

We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
45mo left

Started Jan 2025

Longer than P75 for all trials

Status
not yet 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 Progress26%
Jan 2025Jan 2030

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2030

Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Endometrial CancerEndometrial Intraepithelial NeoplasiaFertility-sparing Surgery

Outcome Measures

Primary Outcomes (1)

  • Relaps of endometrial cancer or EIN after fertility-sparing treatment

    Relaps of endometrial cancer or EIN after fertility-sparing treatment

    from enrollment to 2 years after fertility-sparing treatment

Secondary Outcomes (1)

  • Live birth rate in women that has been treated with fertility-sparing treatment for EC or EIN

    From start of study to 2 years after fertility-sparing treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All women in Sweden

You may qualify if:

  • Fertility sparing treatment of EC and EIN.
  • Years old
  • From start study (Jan 2025 - end study Jan 2028)
  • All centras in Sweden

You may not qualify if:

  • Not English och Swedish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial NeoplasmsEndometrial Hyperplasia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Charlotta CR Riese, MD, PHD-student

CONTACT

+46703440206charlotta.riese@ki.se

Kenny Rodriguez Wallberg, Proffessor

CONTACT

+46 73546 10 71kenny.rodriguez-wallberg@ki.se

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

January 15, 2025

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2030

Last Updated

December 20, 2024

Record last verified: 2024-12