Clinical trial NCT04403867: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
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)
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early stage uterine (endometrial or cervical) cancer, who underwent a sentinel lymph node (SLN) procedure with an identification of lymph nodes metastasis (macrometastasis or low volume disease \[micrometastasis and isolated tumor cells\])

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

Primary outcomes:
measure: Survival (Disease free survival [DFS], overall survival [OS])
timeFrame: through study completion, an average of 3 years
measure: Recurrence rate
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Usage of adjuvant therapy in case of small-volume lymph node disease
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Fabio Martinelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomez-Hidalgo NR, Ramirez PT, Ngo B, Perez-Hoyos S, Coreas N, Sanchez-Iglesias JL, Cabrera S, Franco S, Benavente AP, Gil-Moreno A. Oncologic impact of micrometastases or isolated tumor cells in sentinel lymph nodes of patients with endometrial cancer: a meta-analysis. Clin Transl Oncol. 2020 Aug;22(8):1272-1279. doi: 10.1007/s12094-019-02249-x. Epub 2019 Dec 20.
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citation: Cibula D, Abu-Rustum NR, Dusek L, Zikan M, Zaal A, Sevcik L, Kenter GG, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Lacheta J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol. 2012 Mar;124(3):496-501. doi: 10.1016/j.ygyno.2011.11.037. Epub 2011 Nov 25.
citation: Cibula D, McCluggage WG. Sentinel lymph node (SLN) concept in cervical cancer: Current limitations and unanswered questions. Gynecol Oncol. 2019 Jan;152(1):202-207. doi: 10.1016/j.ygyno.2018.10.007. Epub 2018 Oct 11.