Trials / Recruiting
RecruitingNCT04403867
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Sentinel lymph node (SLN) biosy +/- lymphadenectomy | Evaluation of type and volume of lymph nodal disease |
Timeline
- Start date
- 2020-01-02
- Primary completion
- 2025-01-01
- Completion
- 2027-01-01
- First posted
- 2020-05-27
- Last updated
- 2022-08-17
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04403867. Inclusion in this directory is not an endorsement.