A Multi-center Prospective Study on the Oncological and Reproductive Outcomes and Quality of Life in Young Woman After Fertility-sparing Treatment of Endometrial Cancer and Endometrial Intraepithelial Hyperplasia (PreFerEC/EIN)

December 17, 2024 updated by: Charlotta Riese, Region Stockholm
We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

A multi-center prospective study on the oncological and reproductive outcomes and quality of life in young woman after fertility-sparing treatment of endometrial cancer and endometrial intraepithelial hyperplasia

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All women in Sweden

Description

Inclusion Criteria:

  • Fertility sparing treatment of EC and EIN.
  • 18-45 Years old
  • From start study (Jan 2025 - end study Jan 2028)
  • All centras in Sweden

Exclusion Criteria:

  • Not English och Swedish speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relaps of endometrial cancer or EIN after fertility-sparing treatment
Time Frame: from enrollment to 2 years after fertility-sparing treatment
Relaps of endometrial cancer or EIN after fertility-sparing treatment
from enrollment to 2 years after fertility-sparing treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate in women that has been treated with fertility-sparing treatment for EC or EIN
Time Frame: From start of study to 2 years after fertility-sparing treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2030

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024048701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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