ClinicopathologicalNCT06632431
Clinicopathological Analysis of Endometrial Carcinoma in the View of Old and New International Federation of Gynecology and Obestetrics (FIGO)
An observational study of Clinicopathological and Endometrial Carcinoma, run by Assiut University at 1 site in Egypt.
Trial summary
Assess the percentage change in stage and risk stratification for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system. Investigate the prognostic impact of the FIGO 2023 endometrial staging system on patient survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Clinicopathological, Endometrial Carcinoma, Federation of Gynecology and Obestetrics
- What is being tested?
- Endometrial cancer (EC)
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 1 Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between January 1, 2018, and December 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks.
Who may be able to join
- Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between January 1, 2018, and December 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks.
Who cannot join
- Patients who received neoadjuvant chemotherapy, had recurrent endometrial cancer, had multiple cancers, lacked histopathological slides and formalin-fixed paraffin-embedded blocks or lacked medical records were excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71515
Yousra H Abdelghafour, MBBCH, 00201149264064, yousrahamzawy1997@gmail.com
About this study
Assess the percentage change in stage and risk stratification for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
Investigate the prognostic impact of the FIGO 2023 endometrial staging system on patient survival.
Evaluate how the shift in stage classification between the FIGO 2009 and FIGO 2023 systems influences adjuvant management decisions for endometrial cancer.
Read the detailed description
Endometrial cancer is the commonest gynecological cancer mostly affecting women in the post-menopausal age group . The average age of women diagnosed with endometrial cancer is 60. It's uncommon in women under the age of 45. The vast majority of endometrial cancers are carcinomas (usually adenocarcinomas). The five-year survival rate for endometrial adenocarcinoma following appropriate treatment is 80%. More than 70% of women diagnosed have Federation of Gynecology and Obestetrics (FIGO) stage I cancer, which has the best prognosis. Stage III and especially Stage IV cancers has a worse prognosis, but these are relatively rare, occurring in only 13% of cases. The median survival time for stage III-IV endometrial cancer is nine to ten months.
The FIGO 2023 staging system provides a refined framework for managing endometrial cancer, benefiting patient care and outcomes as the FIGO 2023 staging system for endometrial cancer offers several advantages over the previous FIGO 2009 system
- Improved Prognostic Prediction: The 2023 system predicts survival more accurately, validated by five studies and It adds granularity to prognostic assessment, identifying treatment-relevant subgroups of patients.
- Incorporation of Molecular Measures as The 2023 system integrates molecular parameters, reflecting their impact on prognosis (similar to breast cancer staging)
- Risk Stratification: It incorporates risk stratification, aiding better prognosis definition and treatment decisions.
- Enhanced Understanding of Endometrial Carcinomas: The 2023 system clarifies the diverse biological nature of endometrial cancers, allowing for better-adapted treatment.
- Being tested
- Endometrial cancer (EC)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial cancer (EC)Other
Endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) Histopathological slides for these cases will be reexamined and staged according to both the Federation of Gynecology and Obestetrics (FIGO) 2009 and updated Federation of Gynecology and Obestetrics (FIGO) 2023 endometrial staging systems. Upstaging refers to reclassification to a higher stage in the FIGO 2023 system compared to Federation of Gynecology and Obestetrics (FIGO)2009, while downstaging is the opposite.
All patients underwent lymph node dissection except those with Stage IA-Grades I and II endometrioid endometrial cancer and tumor size <2 cm.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer group | Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) Receives: Other: Endometrial cancer (EC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in stage
Percentage change in stage will be recorded for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
Measured: One years after the start of study
Secondary outcomes (1)
Risk stratification
Risk stratification will be recorded for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
Measured: One years after the start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start10 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClinicopathologicalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yousra hassanin abdelghafour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632431
- Sponsor's protocol ID
- 04-2024-200910
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological Analysis of Endometrial Carcinoma in the View of Old and New International Federation of Gynecology and Obestetrics (FIGO)
- ClinicalTrials.gov ID
- NCT06632431
- Acronym / sponsor ID
- 04-2024-200910
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Oct 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.
Assess the percentage change in stage and risk stratification for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
Investigate the prognostic impact of the FIGO 2023 endometrial staging system on patient survival.
Evaluate how the shift in stage classification between the FIGO 2009 and FIGO 2023 systems influences adjuvant management decisions for endometrial cancer.
Detailed description
Endometrial cancer is the commonest gynecological cancer mostly affecting women in the post-menopausal age group . The average age of women diagnosed with endometrial cancer is 60. It's uncommon in women under the age of 45. The vast majority of endometrial cancers are carcinomas (usually adenocarcinomas). The five-year survival rate for endometrial adenocarcinoma following appropriate treatment is 80%. More than 70% of women diagnosed have Federation of Gynecology and Obestetrics (FIGO) stage I cancer, which has the best prognosis. Stage III and especially Stage IV cancers has a worse prognosis, but these are relatively rare, occurring in only 13% of cases. The median survival time for stage III-IV endometrial cancer is nine to ten months.
The FIGO 2023 staging system provides a refined framework for managing endometrial cancer, benefiting patient care and outcomes as the FIGO 2023 staging system for endometrial cancer offers several advantages over the previous FIGO 2009 system
- Improved Prognostic Prediction: The 2023 system predicts survival more accurately, validated by five studies and It adds granularity to prognostic assessment, identifying treatment-relevant subgroups of patients.
- Incorporation of Molecular Measures as The 2023 system integrates molecular parameters, reflecting their impact on prognosis (similar to breast cancer staging)
- Risk Stratification: It incorporates risk stratification, aiding better prognosis definition and treatment decisions.
- Enhanced Understanding of Endometrial Carcinomas: The 2023 system clarifies the diverse biological nature of endometrial cancers, allowing for better-adapted treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer group | – | Other: Endometrial cancer (EC)Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) |
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 endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between January 1, 2018, and December 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks.
Key inclusion criteria (1 listed)
- Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between January 1, 2018, and December 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks.
Key exclusion criteria (1 listed)
- Patients who received neoadjuvant chemotherapy, had recurrent endometrial cancer, had multiple cancers, lacked histopathological slides and formalin-fixed paraffin-embedded blocks or lacked medical records were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial cancer (EC)Endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) Histopathological slides for these cases will be reexamined and staged according to both the Federation of Gynecology and Obestetrics (FIGO) 2009 and updated Federation of Gynecology and Obestetrics (FIGO) 2023 endometrial staging systems. Upstaging refers to reclassification to a higher stage in the FIGO 2023 system compared to Federation of Gynecology and Obestetrics (FIGO)2009, while downstaging is the opposite. All patients underwent lymph node dissection except those with Stage IA-Grades I and II endometrioid endometrial cancer and tumor size <2 cm. | Other | Endometrial cancer group |
Primary outcome
Percentage change in stage
Time frame: One years after the start of study
Percentage change in stage will be recorded for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
1 secondary outcome
Risk stratification
Time frame: One years after the start of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Clinicopathological and Endometrial Carcinoma, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Oct 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 Egypt. 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?
Contact Yousra H Abdelghafour, MBBCH (00201149264064, yousrahamzawy1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in stage (time frame: One years after the start of study). 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 15 Oct 2024.