Endometrium CancerENCA-1NCT03570866
PET/CT in the Management of Patients With Early Stage Endometrial Cancer
An observational study of Endometrium Cancer, run by Università degli Studi dell'Insubria.
Trial summary
Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrium Cancer
- What is being tested?
- Positron emission tomography and computed tomography and Surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Woman referred for diagnosis of early stage intermediate and high-risk endometrial cancer that undergo PET/CT staging and standard surgical treatment.
Who may be able to join
- Women with diagnosis of early stage intermediate and high-risk endometrial cancer.
Who cannot join
- Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer
Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion > 50% or grade 3 endometrioid lesion with < 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion > 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.
- Conditions
- Endometrium Cancer
- Being tested
- Positron emission tomography and computed tomography, Surgical treatment
- Keywords
- Endometrial cancer, Positron emission tomography
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography and computed tomographyDiagnostic test
Preoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography.
Surgical treatmentProcedure or surgery
Surgical treatment of early stage intermediate and high-risk endometrial cancer by usual practice: peritoneal cytology, total abdominal hysterectomy, bilateral salpingo-oophorectomy, systematic pelvic and para-aortic lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| Early stage endometrial cancer | Women with diagnosis of intermediate and high-risk early stage endometrial cancer. Receives: Diagnostic Test: Positron emission tomography and computed tomography; Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of positron emission tomography and computed tomography
Comparing Positron emission tomography and computed tomography results with Histopathological findings served as the standard of reference. True positive, True negative, False positive, False negative. Sensitivity, Specificity, Negative predictive value, Positive predictive value.
Measured: Through study completion, an average of 5 year
Secondary outcomes (2)
Progression free survival
Events of disease recurrence in the study group
Measured: Through study completion, an average of 5 year
Overall survival
Events of death in the study group
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrium 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Simone Garzon, M.D., Principal investigator, Universita di VeronaAntonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'InsubriaMassimo Franchi, M.D., Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570866
- Sponsor's protocol ID
- ENCA-1
- Acronym
- ENCA-1
- Status last verified
- Sep 2021
- First submitted
- 31 May 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03570866
- Acronym / sponsor ID
- ENCA-1 / ENCA-1
- Conditions
- Endometrium Cancer
- Keywords
- Endometrial cancer, Positron emission tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Jun 2018 (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.
Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion > 50% or grade 3 endometrioid lesion with < 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion > 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage endometrial cancer | – | Diagnostic Test: Positron emission tomography and computed tomography, Procedure: Surgical treatmentWomen with diagnosis of intermediate and high-risk early stage endometrial cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Woman referred for diagnosis of early stage intermediate and high-risk endometrial cancer that undergo PET/CT staging and standard surgical treatment.
Key inclusion criteria (1 listed)
- Women with diagnosis of early stage intermediate and high-risk endometrial cancer.
Key exclusion criteria (1 listed)
- Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT
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 |
|---|---|---|
| Positron emission tomography and computed tomographyPreoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography. | Diagnostic test | Early stage endometrial cancer |
| Surgical treatmentSurgical treatment of early stage intermediate and high-risk endometrial cancer by usual practice: peritoneal cytology, total abdominal hysterectomy, bilateral salpingo-oophorectomy, systematic pelvic and para-aortic lymphadenectomy. | Procedure or surgery | Early stage endometrial cancer |
Primary outcome
Diagnostic accuracy of positron emission tomography and computed tomography
Time frame: Through study completion, an average of 5 year
Comparing Positron emission tomography and computed tomography results with Histopathological findings served as the standard of reference. True positive, True negative, False positive, False negative. Sensitivity, Specificity, Negative predictive value, Positive predictive value.
2 secondary outcomes
Progression free survival
Time frame: Through study completion, an average of 5 year
Overall survival
Time frame: Through study completion, an average of 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Endometrium Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Simone Garzon, M.D. principal investigator
Universita di Verona
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
Massimo Franchi, M.D. principal investigator
Universita di Verona
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrium Cancer, run by Università degli Studi dell'Insubria.
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 30 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Simone Laganà, M.D. (+39 329 6279579, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of positron emission tomography and computed tomography (time frame: Through study completion, an average of 5 year). 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 30 Sep 2021.