The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

Study Overview
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Brief Summary
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The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined. This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed. This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.

Official Title
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The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study

Conditions
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Endometrial Cancer, Cervical Cancer, Sentinel Lymph Node, Micrometastasis, Sentinel Lymph Node Biopsy, Endometrium Tumor, Endometrial Neoplasms, Cervical Neoplasm, Cervical Tumor, Lymph Node Metastases, Lymph Node Disease

Intervention / Treatment
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* Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early stage endometrial cancer scheduled for SLN procedure Early stage cervical cancer scheduled for SLN procedure Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis Presence of lymph nodes metastasis (macrometastasis or low volume disease [micrometastasis and isolated tumor cells]) Exclusion Criteria: Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer Advanced/metastatic endometrial cancer Locally advanced/metastatic cervical cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrial cancer patients<br>Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells). | Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy<br>* Evaluation of type and volume of lymph nodal disease<br>* Other names: Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA);|
| Cervical cancer patients<br>Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells). | Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy<br>* Evaluation of type and volume of lymph nodal disease<br>* Other names: Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival (Disease free survival [DFS], overall survival [OS]) | Evaluation of survival outcomes according to the type and volume of lymph nodal disease | through study completion, an average of 3 years | 
| Recurrence rate | Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease | through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of adjuvant therapy in case of small-volume lymph node disease | Evaluation of the number of patients receiving or not receiving an adjuvant treatment (radiation therapy, chemotherapy, combinations of the two) in case of small-volume lymph node disease (ITC and micro metastasis) | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, cervical cancer, sentinel lymph node, low volume disease, survival, recurrence rate, adjuvant therapy, micrometastases, isolated tumor cell, macrometastases, ultrastaging, one-step nucleic acid amplification (OSNA)