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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Enrolling

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

Treatments: Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04403867

INT 135/19

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Endometrial cancer patients

Description:

Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).

Treatment:

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

Cervical cancer patients

Description:

Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).

Treatment:

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