Endometrial CancerNCT05707312
Staging Endometrial caNcer Based on molEcular ClAssification
An observational study of Endometrial Cancer and Lymph Node Metastasis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The SENECA study tries to evaluate the rate of lymph node involvement depending on the molecular subgroup in early-stage endometrial cancer (I/II) patients undergoing surgery as part of their treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Lymph Node Metastasis, Sentinel Lymph Node
- How many people
- 1,032 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with early-stage (FIGO stage I-II) EC that underwent surgical treatment with lymph node evaluation between January 2021 to December 2022, both included.
Who may be able to join
- Patient was operated during 2021-2022
- Histological confirmation of Endometrial Cancer with endometrioid histology or high risk histology (serous, clear cell, carcinosarcoma and mixed histologies)
- Preoperative FIGO stage I or II by MRI or US
- Preoperative CT-Scan or PET-CT without evidence of local or distant disease (could be omitted in low-risk and intermediate risk endometrial carcinoma with low grade histology)
- Surgical protocol according to ESGO/ESTRO/ESP guidelines
- A detailed sentinel lymph node study protocol must be accredited, either by ultra-staging or OSNA
- Molecular analysis performed on the pathology specimen according to ESGO/ESTRO/ESP guidelines (POLE mutation analysis could be omitted in low-risk and intermediate risk endometrial carcinoma with low grade histology).
Who cannot join
- Pregnant women
- Previous hysterectomy
- Previous pelvic/para-aortic lymphadenectomy
- Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)
- Past medical history of any invasive tumor
- History of previous abdominal or pelvic radiotherapy of any type (including braquitherapy)
- History of preoperative neoadjuvant chemotherapy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Enrique Chacon, MD, 948 25 54 00
About this study
The SENECA study tries to evaluate the rate of lymph node involvement depending on the molecular subgroup in early-stage endometrial cancer (I/II) patients undergoing surgery as part of their treatment.
Read the detailed description
The management of endometrial cancer (EC) is currently undergoing a true revolution in terms of diagnosis and treatment. Since 2013 and thanks to the TCGA project1 (The Cancer Genome Atlas), four distinct molecular subgroups (POLE, MMR-D, Copy number low, Copy number high) with distinct prognostic implications were identified.
Subsequently, PROMISE study2 brought this "new era" closer to daily clinical practice. These new findings led ESGO3 (European Society of Gynecologic Oncology) to decide to integrate this molecular classification into the definition of the different risk groups.
Currently, thanks to the retrospective analysis of the PORTEC-3 cohort4,5, we know that these four molecular subgroups may present differences in survival in high-risk patients depending on the type of treatment proposed, chemoradiotherapy vs. adjuvant radiotherapy. This question will be answered by the RAINBO trial6 (Refining Adjuvant treatment IN endometrial cancer Based On molecular profile).
On the other hand, the surgical management of early endometrial cancer (stage I/II) has been changing for some years now, especially with regard to nodal staging, from modulation of treatment depending on the risk group (pelvic lymphadenectomy +/- sentinel lymph node (SLN) for low and intermediate risk groups vs. aortopelvic lymphadenectomy +/- SLN for those at high risk) to a generalization of treatment based on detailed study of the sentinel node following the algorithm described by the group of Abu-Rustum NR et al7.
Just as the RAINBO study will try to clarify the type of adjuvant treatment necessary for each molecular subgroup, we do not currently know if it could be possible to tailor the type of lymph node staging in early EC (the most common and most frequent in our daily clinical practice) depending on the molecular subgroup8,9.
We therefore propose a study to evaluate the lymph node involvement rate depending on the molecular subgroup in early-stage EC (I/II).
- Medical subject headings
- Endometrial Neoplasms, Lymphatic Metastasis
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 |
|---|---|---|
| POLEmut (POLE mutant endometrial cancer patients) | POLE mutant endometrial cancer patients | |
| MMRd (mismatch repair deficient endometrial cancer patients) | mismatch repair deficient endometrial cancer patients | |
| NSMP (no specific molecular profile endometrial cancer patients to NSMP) | no specific molecular profile endometrial cancer patients to NSMP | |
| p53abn (p53 abnormal endometrial cancer patients) | p53 abnormal endometrial cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node involvement rate
Lymph node involvement rate (sentinel) for each molecular subtype in patients with stage I/II EC.(percentage)
Measured: 1 month after the intervention/procedure/surgery
Secondary outcomes (2)
Lymph node involvement rate
Lymph node involvement rate (sentinel and non-sentinel) for each prognostic risk group in patients with stage I/II EC.
Measured: 1 month after the intervention/procedure/surgery
Compliance of ESGO quality Indicators.
Compliance of ESGO quality Indicators for center (percentage)
Measured: 1 month after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- 1,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Chiva, MD PHD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707312
- Sponsor's protocol ID
- SENECA
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging Endometrial caNcer Based on molEcular ClAssification
- ClinicalTrials.gov ID
- NCT05707312
- Acronym / sponsor ID
- SENECA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,032 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Jan 2023 (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.
The SENECA study tries to evaluate the rate of lymph node involvement depending on the molecular subgroup in early-stage endometrial cancer (I/II) patients undergoing surgery as part of their treatment.
Detailed description
The management of endometrial cancer (EC) is currently undergoing a true revolution in terms of diagnosis and treatment. Since 2013 and thanks to the TCGA project1 (The Cancer Genome Atlas), four distinct molecular subgroups (POLE, MMR-D, Copy number low, Copy number high) with distinct prognostic implications were identified.
Subsequently, PROMISE study2 brought this "new era" closer to daily clinical practice. These new findings led ESGO3 (European Society of Gynecologic Oncology) to decide to integrate this molecular classification into the definition of the different risk groups.
Currently, thanks to the retrospective analysis of the PORTEC-3 cohort4,5, we know that these four molecular subgroups may present differences in survival in high-risk patients depending on the type of treatment proposed, chemoradiotherapy vs. adjuvant radiotherapy. This question will be answered by the RAINBO trial6 (Refining Adjuvant treatment IN endometrial cancer Based On molecular profile).
On the other hand, the surgical management of early endometrial cancer (stage I/II) has been changing for some years now, especially with regard to nodal staging, from modulation of treatment depending on the risk group (pelvic lymphadenectomy +/- sentinel lymph node (SLN) for low and intermediate risk groups vs. aortopelvic lymphadenectomy +/- SLN for those at high risk) to a generalization of treatment based on detailed study of the sentinel node following the algorithm described by the group of Abu-Rustum NR et al7.
Just as the RAINBO study will try to clarify the type of adjuvant treatment necessary for each molecular subgroup, we do not currently know if it could be possible to tailor the type of lymph node staging in early EC (the most common and most frequent in our daily clinical practice) depending on the molecular subgroup8,9.
We therefore propose a study to evaluate the lymph node involvement rate depending on the molecular subgroup in early-stage EC (I/II).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POLEmut (POLE mutant endometrial cancer patients) | – | –POLE mutant endometrial cancer patients |
| MMRd (mismatch repair deficient endometrial cancer patients) | – | –mismatch repair deficient endometrial cancer patients |
| NSMP (no specific molecular profile endometrial cancer patients to NSMP) | – | –no specific molecular profile endometrial cancer patients to NSMP |
| p53abn (p53 abnormal endometrial cancer patients) | – | –p53 abnormal endometrial cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early-stage (FIGO stage I-II) EC that underwent surgical treatment with lymph node evaluation between January 2021 to December 2022, both included.
Key inclusion criteria (7 listed)
- Patient was operated during 2021-2022
- Histological confirmation of Endometrial Cancer with endometrioid histology or high risk histology (serous, clear cell, carcinosarcoma and mixed histologies)
- Preoperative FIGO stage I or II by MRI or US
- Preoperative CT-Scan or PET-CT without evidence of local or distant disease (could be omitted in low-risk and intermediate risk endometrial carcinoma with low grade histology)
- Surgical protocol according to ESGO/ESTRO/ESP guidelines
Key exclusion criteria (7 listed)
- Pregnant women
- Previous hysterectomy
- Previous pelvic/para-aortic lymphadenectomy
- Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)
- Past medical history of any invasive tumor
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
Sentinel lymph node involvement rate
Time frame: 1 month after the intervention/procedure/surgery
Lymph node involvement rate (sentinel) for each molecular subtype in patients with stage I/II EC.(percentage)
2 secondary outcomes
Lymph node involvement rate
Time frame: 1 month after the intervention/procedure/surgery
Compliance of ESGO quality Indicators.
Time frame: 1 month after the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Related trials for Endometrial Cancer
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 3
HB0025-C-0301: A Study to Investigate HB0025 Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent MMR-proficient Endometrial Cancer
First-line pMMR Endometrial Cancer
Active, not recruitingPhase 3
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Endometrial Cancer
Not yet recruitingPhase 2
Adaptive Radiotherapy for Safe Hypofractionation
Cancer, Endometrial Cancer
RecruitingPhase 1
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
Ovarian Cancer, Breast Cancer
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.
Luis Chiva, MD PHD principal investigator
Clinica Universidad de Navarra
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 Lymph Node Metastasis, run by Clinica Universidad de Navarra, Universidad de Navarra 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 7 inclusion and 7 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 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Chacon, MD (948 25 54 00 ext. 6016, echaconc@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel lymph node involvement rate (time frame: 1 month after the intervention/procedure/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 31 Jan 2023.