Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04403867

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endometrial Cancer Cervical Cancer Cervical Neoplasm Cervical Tumor Endometrial Neoplasms Endometrium Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Lymph Node Disease Lymph Node Metastases Lymphatic Metastasis Micrometastasis Neoplasm Metastasis Neoplasm Micrometastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Sentinel Lymph Node Sentinel Lymph Node Biopsy Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location status: Recruiting

Location contact

Fabio Martinelli, MD

CONTACT

[email protected]

+390223903322

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel lymph node (SLN) biosy +/- lymphadenectomy

Procedure

Evaluation of type and volume of lymph nodal disease

Other names: Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA)

Primary outcomes

  1. Survival (Disease free survival [DFS], overall survival [OS])

    Time frame: 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

    Time frame: 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 outcomes

  1. Usage of adjuvant therapy in case of small-volume lymph node disease

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Martinelli, MD

CONTACT

[email protected]

+390223903322

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study 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

Acronym: ITCMicroUtCa

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
May 27, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.