NCT04403867 The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
| NCT ID | NCT04403867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Endometrial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-01-02 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-01-02 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Fabio Martinelli, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Frequently Asked Questions
Who can join the NCT04403867 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04403867 currently recruiting?
Yes, NCT04403867 is actively recruiting participants. Contact the research team at fabio.martinelli@istitutotumori.mi.it for enrollment information.
Where is the NCT04403867 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT04403867 clinical trial?
NCT04403867 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The principal investigator is Fabio Martinelli, MD at Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The trial plans to enroll 500 participants.
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