Endometrial CancerNCT06584630
Molecular Classification of Endometrial Cancer: Impact on Adjuvant Treatment Planning.
An observational study of Endometrial Cancer, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Endometrial cancer patients that underwent surgery and were tested for molecular analysis (POLE, MSI, p53)
Who may be able to join
- Histological confirmation of endometrial cancer.
- Surgical treatment at our Gynecological - Oncology Unit.
Who cannot join
- Refusal to be tested for the molecular classification
- Presence of a synchronous neoplasm.
Trial locations and contacts
1 site in 1 country.
Greece1 site
1st Department of Obstetrics & Gynecology, AUTh, "Papageorgiou" Hospital
Thessaloniki
About this study
Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients.
- Conditions
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endometrial cancer patients that underwent molecular classification | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidisciplinary Team Board decision change
MDT decision for adjuvant treatment (Rate of adjuvant treatment change)
Measured: 2 years (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Zouzoulas, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584630
- Sponsor's protocol ID
- 37577
- Status last verified
- Sep 2024
- First submitted
- 4 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Classification of Endometrial Cancer: Impact on Adjuvant Treatment Planning.
- ClinicalTrials.gov ID
- NCT06584630
- Acronym / sponsor ID
- 37577
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Sep 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.
Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrial cancer patients that underwent molecular classification | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Endometrial cancer patients that underwent surgery and were tested for molecular analysis (POLE, MSI, p53)
Key inclusion criteria (2 listed)
- Histological confirmation of endometrial cancer.
- Surgical treatment at our Gynecological - Oncology Unit.
Key exclusion criteria (2 listed)
- Refusal to be tested for the molecular classification
- Presence of a synchronous neoplasm.
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
Multidisciplinary Team Board decision change
Time frame: 2 years (study completion)
MDT decision for adjuvant treatment (Rate of adjuvant treatment change)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidisciplinary Team Board decision change (time frame: 2 years (study completion)). 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 19 Sep 2024.