Endometrial CancerMyoNoneNCT07838207
Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
An observational study of Endometrial Cancer and Endometrial Carcinoma (EC), run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This multicenter retrospective observational cohort study aims to evaluate the prognosis of patients with non-myoinvasive endometrial cancer harbouring high-risk molecular features by determining the rate of lymph node involvement (assessed by sentinel lymph node biopsy and/or lymphadenectomy), evaluating recurrence… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Carcinoma (EC), p53abn
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2026to 31 Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with EC between 2010 and 2025 with: * p53-abnormal (p53-abn) endometrial cancer without myometrial invasion * ER-negative NSMP tumours without myometrial invasion * High-grade NSMP tumours without myometrial invasion
Who may be able to join
- Patients over 18 years old.
- Patients with:
- 2.1. p53-abnormal (p53-abn) endometrial carcinoma. 2.2. ER-negative NSMP tumours. 2.3. High-grade NSMP tumours. POLE mutations assessment is not mandatory. MMR and p53 status is mandatory, according to ESGO criteria.
- In whom:
- No myometrial invasion is present in the final surgical specimen (nor cervical or adnexal invasion).
- Tumours are identified by endometrial biopsy or hysteroscopic polypectomy with no residual tumour in the final surgical specimen (these cases will also be considered tumours without myometrial invasion).
- Patients who underwent nodal staging, either with pelvic sentinel lymph node biopsy, associated with pelvic and/or para-aortic lymphadenectomy, or staged by lymphadenectomy alone.
- 3.1. To assess the rate of lymph node involvement, we will analyze tumors with the previous molecular characteristics mentioned and no myometrial invasion, regardless of whether lymph node involvement is present. Stage IIIC tumours will not be excluded; cases will be selected based on the absence of myometrial infiltration in the final pathology specimen. 3.2. On the other hand, for the survival statistical analyses, only patients with a final stage IC (FIGO 2023) will be included.
Who cannot join
- Patients who do not meet the above inclusion criteria and who additionally present with the following conditions will be excluded:
- Molecular profile not available.
- Absence of nodal staging (sentinel lymph node biopsy or lymphadenectomy)
- Inadequate follow-up.
- Mismatch repair-deficient tumors.
- POLE-ultramutated tumors, when identified.
- Incomplete information regarding adjuvant treatment.
- Presence of myometrial invasion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08028
Anna A Luzarraga Aznar, MD PhD, +34665644810, ana.luzarraga@vallhebron.cat
Eloi E Sirvent Mestres, MD, +34646785650, eloi.sirvent.mestres@gmail.com
About this study
Official title: MyoNone: Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
This multicenter retrospective observational cohort study aims to evaluate the prognosis of patients with non-myoinvasive endometrial cancer harbouring high-risk molecular features by determining the rate of lymph node involvement (assessed by sentinel lymph node biopsy and/or lymphadenectomy), evaluating recurrence rates, progression-free survival (PFS) and overall survival (OS), and comparing oncological outcomes according to different adjuvant treatments.
The study will include patients with the following molecular subgroups of non-myoinvasive endometrial cancer:
Read more
- p53-abnormal tumours without myometrial invasion.
- High-grade NSMP tumours without myometrial invasion.
- ER-negative NSMP tumours without myometrial invasion.
Participating centres will be invited to retrospectively identify eligible patients diagnosed between 2010 and 2025 and enter anonymised data into a standardised REDCap database. Given the rarity of these clinical scenarios, international collaboration is essential to generate robust evidence that may help inform future clinical guidelines and optimize patient management.
- Conditions
- Endometrial Cancer, Endometrial Carcinoma (EC), p53abn
- Keywords
- MyoNone, Endometrial cancer, Molecular profile, Endometrial Carcinoma, Non Myoinvasive Endometrial Carcinoma, Recurrence, Lymph Node Involvement, p53-abnormal, ER-negative NSMP, High-grade NSMP, p53abn, NSMP
- Medical subject headings
- Endometrial Neoplasms, Recurrence
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 |
|---|---|---|
| p53-abnormal tumours without myometrial invasion | Not described | |
| High-grade NSMP tumours without myometrial invasion. | Not described | |
| ER-negative NSMP tumours without myometrial invasion. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of lymph node involvement
Assessed by sentinel lymph node biopsy and/or lymphadenectomy in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion.
Measured: At primary surgery
Secondary outcomes (5)
Pattern of recurrence
Number and anatomical location of recurrence in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Measured: Up to 10 years
Progression-free survival (PFS)
In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Measured: Up to 10 years
Overall survival (OS)
In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Measured: Up to 10 years
OS according to adjuvant treatment
OS according to adjuvant treatment received in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion, comparing:
- No adjuvant treatment
- Radiotherapy or brachytherapy
- Chemotherapy ± radiotherapy or brachytherapy.
Measured: Up to 10 years
PFS according to adjuvant treatment
PFS according to adjuvant treatment received in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion, comparing:
- No adjuvant treatment,
- Radiotherapy or brachytherapy
- Chemotherapy ± radiotherapy or brachytherapy.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 May 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (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 Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana A Luzarraga Aznar, MD PhD, Study chair, Hospital Universitari Vall d'Hebron Research InstituteAna A Luzarraga Aznar, MD PhD, Principal investigator, Hospital Universitari Vall d'Hebron Research InstituteAntonio A Gil Moreno, MD, PhD, Study director, Hospital Universitari Vall d'Hebron Research InstituteEloi E Sirvent Mestres, MD, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838207
- Sponsor's protocol ID
- PR(AMI)008/2026
- Acronym
- MyoNone
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2026
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyoNone: Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07838207
- Acronym / sponsor ID
- MyoNone / PR(AMI)008/2026
- Conditions
- Endometrial Cancer, Endometrial Carcinoma (EC), p53abn
- Keywords
- MyoNone, Endometrial cancer, Molecular profile, Endometrial Carcinoma, Non Myoinvasive Endometrial Carcinoma, Recurrence, Lymph Node Involvement, p53-abnormal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2026 (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.
This multicenter retrospective observational cohort study aims to evaluate the prognosis of patients with non-myoinvasive endometrial cancer harbouring high-risk molecular features by determining the rate of lymph node involvement (assessed by sentinel lymph node biopsy and/or lymphadenectomy), evaluating recurrence rates, progression-free survival (PFS) and overall survival (OS), and comparing oncological outcomes according to different adjuvant treatments.
The study will include patients with the following molecular subgroups of non-myoinvasive endometrial cancer:
- p53-abnormal tumours without myometrial invasion.
- High-grade NSMP tumours without myometrial invasion.
- ER-negative NSMP tumours without myometrial invasion.
Participating centres will be invited to retrospectively identify eligible patients diagnosed between 2010 and 2025 and enter anonymised data into a standardised REDCap database. Given the rarity of these clinical scenarios, international collaboration is essential to generate robust evidence that may help inform future clinical guidelines and optimize patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| p53-abnormal tumours without myometrial invasion | – | – |
| High-grade NSMP tumours without myometrial invasion. | – | – |
| ER-negative NSMP tumours without myometrial invasion. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with EC between 2010 and 2025 with: * p53-abnormal (p53-abn) endometrial cancer without myometrial invasion * ER-negative NSMP tumours without myometrial invasion * High-grade NSMP tumours without myometrial invasion
Key inclusion criteria (8 listed)
- Patients over 18 years old.
- Patients with:
- 2.1. p53-abnormal (p53-abn) endometrial carcinoma. 2.2. ER-negative NSMP tumours. 2.3. High-grade NSMP tumours. POLE mutations assessment is not mandatory. MMR and p53 status is mandatory, according to ESGO criteria.
- Patients who underwent nodal staging, either with pelvic sentinel lymph node biopsy, associated with pelvic and/or para-aortic lymphadenectomy, or staged by lymphadenectomy alone.
- 3.1. To assess the rate of lymph node involvement, we will analyze tumors with the previous molecular characteristics mentioned and no myometrial invasion, regardless of whether lymph node involvement is present. Stage IIIC tumours will not be excluded; cases will be selected based on the absence of myometrial infiltration in the final pathology specimen. 3.2. On the other hand, for the survival statistical analyses, only patients with a final stage IC (FIGO 2023) will be included.
Key exclusion criteria (8 listed)
- Patients who do not meet the above inclusion criteria and who additionally present with the following conditions will be excluded:
- Molecular profile not available.
- Absence of nodal staging (sentinel lymph node biopsy or lymphadenectomy)
- Inadequate follow-up.
- Mismatch repair-deficient tumors.
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
Rate of lymph node involvement
Time frame: At primary surgery
Assessed by sentinel lymph node biopsy and/or lymphadenectomy in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion.
5 secondary outcomes
Pattern of recurrence
Time frame: Up to 10 years
Progression-free survival (PFS)
Time frame: Up to 10 years
Overall survival (OS)
Time frame: Up to 10 years
OS according to adjuvant treatment
Time frame: Up to 10 years
PFS according to adjuvant treatment
Time frame: Up to 10 years
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 24 Sep 2026.
- 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.
Ana A Luzarraga Aznar, MD PhD study chair
Hospital Universitari Vall d'Hebron Research Institute
Ana A Luzarraga Aznar, MD PhD principal investigator
Hospital Universitari Vall d'Hebron Research Institute
Antonio A Gil Moreno, MD, PhD study director
Hospital Universitari Vall d'Hebron Research Institute
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 and Endometrial Carcinoma (EC), run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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 Spain. 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?
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 Ana A Luzarraga Aznar, MD, PhD (+34665644810, ana.luzarraga@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of lymph node involvement (time frame: At primary surgery). 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 24 Sep 2026.