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
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
- Name: Charlotta CR Riese, MD, PHD-student
- Phone Number: +46703440206
- Email: charlotta.riese@ki.se
Study Contact Backup
- Name: Kenny Rodriguez Wallberg, Proffessor
- Phone Number: +46 73546 10 71
- Email: kenny.rodriguez-wallberg@ki.se
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
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
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Neoplasms
- Hyperplasia
- Endometrial Neoplasms
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.