Endometrial CancerPreFerEC/EINNCT06745427
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
An observational study of Endometrial Cancer and Endometrial Intraepithelial Neoplasia, run by Region Stockholm.
Trial summary
We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Intraepithelial Neoplasia, Fertility-sparing Surgery
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 15 Jan 2030
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All women in Sweden
Who may be able to join
- Fertility sparing treatment of EC and EIN.
- 18-45 Years old
- From start study (Jan 2025 - end study Jan 2028)
- All centras in Sweden
Who cannot join
- Not English och Swedish speaking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia
Read the 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
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Relaps of endometrial cancer or EIN after fertility-sparing treatment
Relaps of endometrial cancer or EIN after fertility-sparing treatment
Measured: 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
Live birth rate in women that has been treated with fertility-sparing treatment for EC or EIN
Measured: From start of study to 2 years after fertility-sparing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2030 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Charlotta Riese, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745427
- Sponsor's protocol ID
- 2024048701
- Acronym
- PreFerEC/EIN
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06745427
- Acronym / sponsor ID
- PreFerEC/EIN / 2024048701
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 20 Dec 2024 (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.
We will investigate the safety and efficiency of fertility-sapring treatment in ypung women witg endometrial cancer and endometrial intraepithelial hyperplasia
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women in Sweden
Key inclusion criteria (4 listed)
- Fertility sparing treatment of EC and EIN.
- 18-45 Years old
- From start study (Jan 2025 - end study Jan 2028)
- All centras in Sweden
Key exclusion criteria (1 listed)
- Not English och Swedish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
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 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Endometrial Intraepithelial Neoplasia, run by Region Stockholm.
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 1 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: opening soon, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Charlotta CR Riese, MD, PHD-student (+46703440206, charlotta.riese@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relaps of endometrial cancer or EIN after fertility-sparing treatment (time frame: from enrollment to 2 years after fertility-sparing treatment). 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 20 Dec 2024.