Endometrial NeoplasmsPOLE-ENDNCT06409039
POLE-END REAL LIFE: Endometrial Cancer Early Stages I-II and Advanced Stages III and IV Evaluation of POLE as a Prognostic Factor. Participants Are Women >= 18 Years Old, With the Pole Mutation
An observational study of Endometrial Neoplasms, run by Azienda Ulss 2 Marca Trevigiana at 2 sites in Italy.
Trial summary
POLE-END is a non-profit, observational, retrospective and prospective study which aims to analyze the clinical course of patients with POLE-mutated endometrial cancer with evaluation of Recurrence-Free Survival (RFS), defined as the interval of time between the diagnosis of POLE-mutated endometrial carcinoma and the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Sep 2023to 31 Dec 2024
- How long will I take part?
- 5 Years
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female Patients aged > 18 years with histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020. Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation.
Who may be able to join
- Patients aged > 18 years;
- Histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020;
- Clinical Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation;
- Signing of the informed consent to participate in the study and consent to the processing of personal data.
Who cannot join
- Patients with endometrial cancer without POLE mutation.
- Patients whose POLE status has been assessed by other methods.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Aulss2 Marca Trevigiana Ospedale Ca Foncello
Treviso, TV, 31100
Aulss2 Marca Trevigiana Ospedale Ca Foncello
Treviso, Veneto, 31100
About this study
Official title: STUDIO POLE-END REAL LIFE: Carcinoma Dell'Endometrio Stadi Precoci I-II e Avanzati III e IV Valutazione di POLE Come Fattore Prognostico
POLE-END is a non-profit, observational, retrospective and prospective study which aims to analyze the clinical course of patients with POLE-mutated endometrial cancer with evaluation of Recurrence-Free Survival (RFS), defined as the interval of time between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis). In particular, the investigator want to study the influence of the POLE mutation on the survival of patients and therefore on the appearance of relapses by collecting only clinical and anatomopathological-molecular data.
The study also has the secondary objective of correlating the clinical outcome with known prognostic factors and with the treatments administered.
Read more
The data will be collected on a specific Data Collection Form, made anonymous and sent to the promoting center for final analysis.
The study will be conducted according to the attached protocol, in compliance with the rules of Good Clinical Practice.
The treatment of patients will take place according to normal clinical practice and there are no additional costs borne by the Company and the Regional Health Service. Patient enrollment will take place within the centers belonging to the MITO group that have signed up.
Patients will be followed in their respective centers for the duration of their treatments and up to the fifth year after the initial diagnosis of endometrial cancer. The number of patients enrolled for this study will be approximately 80 and will have a maximum overall duration of 9 years.
As a non-profit studio, we request exemption from paying research evaluation costs.
Read the detailed description
The molecular classification of endometrial carcinoma and the resulting studies have contributed to the recent ESGO/ESTRO/ESP guidelines for the management of patients diagnosed with endometrial carcinoma . To date, however, this molecular classification has mostly been performed in the context of clinical trials or in retrospective research contexts and is only now beginning to be implemented in the clinical workflow.
Endometrial carcinomas with pathogenic mutations of the POLE gene have demonstrated an excellent clinical outcome in terms of RFS and OS in the early stages of the disease (stage I and II), especially in high-grade carcinomas. Furthermore, 3-5% of endometrial carcinomas present multiple molecular alterations. In particular, the literature suggests that POLE-mutated cases that are at the same time TP53-mutated or MMR-deficient have a clinical behavior like cases with only POLE alteration. Overall, POLE-mutated tumors would therefore not require adjuvant therapy unlike carcinomas belonging to other molecular groups (TP53-mutated, MMRd and NSMP) or which are attributable to the intermediate-high risk group according to the guidelines . The PORTEC-4A study is also underway for this group.In a cohort of 23 POLE-mutated endometrial carcinomas Stasenko and colleagues documented recurrence in 17% of cases, suggesting caution in omitting adjuvant therapy. A very recent work on 310 endometrial carcinomas studied from a morpho-molecular perspective, including 15 POLE-mutated tumors, however has follow-up data that are too short to be conclusive (11.6 months on average). Advanced stage POLE-mutated carcinomas (III-IVA) are also rare and poorly described in the literature. It therefore seems appropriate to prospectively collect real-world clinical-pathological data on a large scale from patients with POLE-mutated tumors with the aim of investigating the histo-molecular characteristics of patients who undergo relapse and being able to compare them with those of non-relapsed patients. relapse. The relative rarity of POLE-mutated tumors in general and in particular of those that relapse suggests the need to involve multiple centers in order to obtain a significant number.
- Conditions
- Endometrial Neoplasms
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
POLE-END REAL LIFE STUDY: endometrial cancer early stages I-II and advanced stages III and IV evaluation of POLE as a prognostic factor
Recurrence-Free Survival (RFS) defined as the time interval between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis),The RFS will be calculated with the Kaplan-Meier method and the 3- and 5-year values will be reported with their 95% confidence intervals, Follow-up data will be collected 3 and 5 years after diagnosis of endometrial cancer,the results will be described by means, medians, standard deviations and interquartile ranges if relating to quantitative variables and by absolute and relative frequencies for qualitative variables.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start4 Sep 2023
- Primary completion1 Mar 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ulss 2 Marca Trevigiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artioli Grazia, Azienda Ulss 2 Marca Trevigiana
- Investigators
- GRAZIA ARTIOLI, Principal investigator, AULSS2 MARCA TREVIGIANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409039
- Sponsor's protocol ID
- GRAZIA ARTIOLI
- Acronym
- POLE-END
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 10 May 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDIO POLE-END REAL LIFE: Carcinoma Dell'Endometrio Stadi Precoci I-II e Avanzati III e IV Valutazione di POLE Come Fattore Prognostico
- ClinicalTrials.gov ID
- NCT06409039
- Acronym / sponsor ID
- POLE-END / GRAZIA ARTIOLI
- Conditions
- Endometrial Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ulss 2 Marca TrevigianaUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 May 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.
POLE-END is a non-profit, observational, retrospective and prospective study which aims to analyze the clinical course of patients with POLE-mutated endometrial cancer with evaluation of Recurrence-Free Survival (RFS), defined as the interval of time between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis). In particular, the investigator want to study the influence of the POLE mutation on the survival of patients and therefore on the appearance of relapses by collecting only clinical and anatomopathological-molecular data.
The study also has the secondary objective of correlating the clinical outcome with known prognostic factors and with the treatments administered.
The data will be collected on a specific Data Collection Form, made anonymous and sent to the promoting center for final analysis.
The study will be conducted according to the attached protocol, in compliance with the rules of Good Clinical Practice.
The treatment of patients will take place according to normal clinical practice and there are no additional costs borne by the Company and the Regional Health Service. Patient enrollment will take place within the centers belonging to the MITO group that have signed up.
Patients will be followed in their respective centers for the duration of their treatments and up to the fifth year after the initial diagnosis of endometrial cancer. The number of patients enrolled for this study will be approximately 80 and will have a maximum overall duration of 9 years.
As a non-profit studio, we request exemption from paying research evaluation costs.
Detailed description
The molecular classification of endometrial carcinoma and the resulting studies have contributed to the recent ESGO/ESTRO/ESP guidelines for the management of patients diagnosed with endometrial carcinoma . To date, however, this molecular classification has mostly been performed in the context of clinical trials or in retrospective research contexts and is only now beginning to be implemented in the clinical workflow.
Endometrial carcinomas with pathogenic mutations of the POLE gene have demonstrated an excellent clinical outcome in terms of RFS and OS in the early stages of the disease (stage I and II), especially in high-grade carcinomas. Furthermore, 3-5% of endometrial carcinomas present multiple molecular alterations. In particular, the literature suggests that POLE-mutated cases that are at the same time TP53-mutated or MMR-deficient have a clinical behavior like cases with only POLE alteration. Overall, POLE-mutated tumors would therefore not require adjuvant therapy unlike carcinomas belonging to other molecular groups (TP53-mutated, MMRd and NSMP) or which are attributable to the intermediate-high risk group according to the guidelines . The PORTEC-4A study is also underway for this group.In a cohort of 23 POLE-mutated endometrial carcinomas Stasenko and colleagues documented recurrence in 17% of cases, suggesting caution in omitting adjuvant therapy. A very recent work on 310 endometrial carcinomas studied from a morpho-molecular perspective, including 15 POLE-mutated tumors, however has follow-up data that are too short to be conclusive (11.6 months on average). Advanced stage POLE-mutated carcinomas (III-IVA) are also rare and poorly described in the literature. It therefore seems appropriate to prospectively collect real-world clinical-pathological data on a large scale from patients with POLE-mutated tumors with the aim of investigating the histo-molecular characteristics of patients who undergo relapse and being able to compare them with those of non-relapsed patients. relapse. The relative rarity of POLE-mutated tumors in general and in particular of those that relapse suggests the need to involve multiple centers in order to obtain a significant number.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female Patients aged > 18 years with histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020. Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation.
Key inclusion criteria (4 listed)
- Patients aged > 18 years;
- Histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020;
- Clinical Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation;
- Signing of the informed consent to participate in the study and consent to the processing of personal data.
Key exclusion criteria (2 listed)
- Patients with endometrial cancer without POLE mutation.
- Patients whose POLE status has been assessed by other methods.
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
POLE-END REAL LIFE STUDY: endometrial cancer early stages I-II and advanced stages III and IV evaluation of POLE as a prognostic factor
Time frame: 10 years
Recurrence-Free Survival (RFS) defined as the time interval between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis),The RFS will be calculated with the Kaplan-Meier method and the 3- and 5-year values will be reported with their 95% confidence intervals, Follow-up data will be collected 3 and 5 years after diagnosis of endometrial cancer,the results will be described by means, medians, standard deviations and interquartile ranges if relating to quantitative variables and by absolute and relative frequencies for qualitative variables.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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. This study is not recruiting at the moment.
GRAZIA ARTIOLI principal investigator
AULSS2 MARCA TREVIGIANA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms, run by Azienda Ulss 2 Marca Trevigiana at 2 sites in Italy.
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 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
POLE-END REAL LIFE STUDY: endometrial cancer early stages I-II and advanced stages III and IV evaluation of POLE as a prognostic factor (time frame: 10 years). 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 10 May 2024.