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

NCT04403867RecruitingOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

500

Start Date

2020-01-02

Completion Date

2025-01-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Sentinel lymph node (SLN) biosy +/- lymphadenectomy

Conditions

Endometrial CancerCervical CancerSentinel Lymph NodeMicrometastasisSentinel Lymph Node BiopsyEndometrium TumorEndometrial NeoplasmsCervical NeoplasmCervical TumorLymph Node MetastasesLymph Node Disease

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Survival (Disease free survival [DFS], overall survival [OS])

Evaluation of survival outcomes according to the type and volume of lymph nodal disease

Time frame: 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

Time frame: through study completion, an average of 3 year

Secondary Outcomes

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)

Time frame: through study completion, an average of 6 months

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.