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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique Chacon, MD | Contact | 948 25 54 00 | 6016 | echaconc@unav.es |
| Felix Boria, MD | Contact | 948 25 54 00 | 6016 | fboria@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Luis Chiva, MD PHD | Clinica Universidad de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2023 | Jan 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Compliance of ESGO quality Indicators for center (percentage)
| 1 month after the intervention/procedure/surgery |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |