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

RECRUITINGSponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Actively Recruiting
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Started2020-01-02
Est. completion2025-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions12

CancerCervical CancerCervical NeoplasmCervical TumorEndometrial CancerEndometrial NeoplasmsEndometrium TumorLymph Node DiseaseLymph Node MetastasesMicrometastasis

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