Brief Title
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
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
Brief 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.
Study Type
Observational
Primary Outcome
Survival (Disease free survival [DFS], overall survival [OS])
Secondary Outcome
Usage of adjuvant therapy in case of small-volume lymph node disease
Condition
Endometrial Cancer
Intervention
Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Study Arms / Comparison Groups
Endometrial cancer patients
Description: Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
500
Start Date
January 2, 2020
Completion Date
January 2027
Primary Completion Date
January 2025
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Fabio Martinelli, MD, +390223903322, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04403867
Organization ID
INT 135/19
Responsible Party
Principal Investigator
Study Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor
Fabio Martinelli, MD, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date
August 2022