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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04403867

Acronym

ITCMicroUtCa

Enrollment

500

Registered

2020-05-27

Start date

2020-01-02

Completion date

2027-01-31

Last updated

2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Cervical Neoplasm, Cervical Tumor, Endometrial Cancer, Endometrial Neoplasms, Endometrium Tumor, Lymph Node Disease, Lymph Node Metastases, Micrometastasis, Sentinel Lymph Node, Sentinel Lymph Node Biopsy

Keywords

endometrial cancer, cervical cancer, sentinel lymph node, low volume disease, survival, recurrence rate, adjuvant therapy, micrometastases, isolated tumor cell, macrometastases, ultrastaging, one-step nucleic acid amplification (OSNA)

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.

Interventions

PROCEDURESentinel lymph node (SLN) biosy +/- lymphadenectomy

Evaluation of type and volume of lymph nodal disease

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Survival (Disease free survival [DFS], overall survival [OS])	through study completion, an average of 3 years	Evaluation of survival outcomes according to the type and volume of lymph nodal disease
Recurrence rate	through study completion, an average of 3 year	Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease

Secondary

Measure	Time frame	Description
Usage of adjuvant therapy in case of small-volume lymph node disease	through study completion, an average of 6 months	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)

Countries

Italy

Contacts

Primary ContactFabio Martinelli, MD

fabio.martinelli@istitutotumori.mi.it+390223903322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026