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

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04403867
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Jan 2, 2020
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Endometrial cancer patients Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).	Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy; Evaluation of type and volume of lymph nodal disease; Other Names: Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA)
Cervical cancer patients Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).	Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy; Evaluation of type and volume of lymph nodal disease; Other Names: Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA)

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan		Italy	20133

Sponsors and Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

• Principal Investigator: Fabio Martinelli, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fabio Martinelli, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• ClinicalTrials.gov Identifier: NCT04403867
• Other Study ID Numbers: INT 135/19
• First Posted: May 27, 2020
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fabio Martinelli, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: 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)
• Additional relevant MeSH terms: Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Lymphatic Metastasis; Neoplasm Micrometastasis

Study Results

No Results Posted as of Aug 17, 2022