Staging Endometrial caNcer Based on molEcular ClAssification

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer; Sentinel Lymph Node; Lymph Node Metastasis

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 Type: Observational
• Enrollment (Anticipated): 1032

Contacts and Locations

• Study Contact: Name: Enrique Chacon, MD; Phone Number: 6016 948 25 54 00; Email: echaconc@unav.es
• Study Contact Backup: Name: Felix Boria, MD; Phone Number: 6016 948 25 54 00; Email: fboria@unav.es

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Clinica Universidad de Navarra
      • Contact: Enrique Chacon, MD; Phone Number: 948 25 54 00

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sentinel lymph node involvement rate	Lymph node involvement rate (sentinel) for each molecular subtype in patients with stage I/II EC.(percentage)	1 month after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymph node involvement rate	Lymph node involvement rate (sentinel and non-sentinel) for each prognostic risk group in patients with stage I/II EC.	1 month after the intervention/procedure/surgery
Compliance of ESGO quality Indicators.	Compliance of ESGO quality Indicators for center (percentage)	1 month after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Principal Investigator: Luis Chiva, MD PHD, Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2023
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ACTUAL): January 31, 2023

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Neoplastic Processes; Neoplasm Metastasis; Endometrial Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: SENECA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No