The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
ITCMicroUtCa
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2020
CompletedFirst Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedAugust 17, 2022
August 1, 2022
5 years
May 18, 2020
August 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Survival (Disease free survival [DFS], overall survival [OS])
Evaluation of survival outcomes according to the type and volume of lymph nodal disease
through study completion, an average of 3 years
Recurrence rate
Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease
through study completion, an average of 3 year
Secondary Outcomes (1)
Usage of adjuvant therapy in case of small-volume lymph node disease
through study completion, an average of 6 months
Study Arms (2)
Endometrial cancer patients
Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Cervical cancer patients
Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Interventions
Evaluation of type and volume of lymph nodal disease
Eligibility Criteria
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 \[micrometastasis and isolated tumor cells\])
You may qualify if:
- 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 \[micrometastasis and isolated tumor cells\])
You may not qualify if:
- Previous (\<5 years) or concomitant malignancy other than non-melanoma skin cancer
- Advanced/metastatic endometrial cancer
- Locally advanced/metastatic cervical cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Related Publications (11)
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.
PMID: 31863354RESULTIgnatov A, Lebius C, Ignatov T, Ivros S, Knueppel R, Papathemelis T, Ortmann O, Eggemann H. Lymph node micrometastases and outcome of endometrial cancer. Gynecol Oncol. 2019 Sep;154(3):475-479. doi: 10.1016/j.ygyno.2019.07.018. Epub 2019 Jul 22.
PMID: 31345606RESULTPiedimonte S, Richer L, Souhami L, Arseneau J, Fu L, Gilbert L, Alfieri J, Jardon K, Zeng XZ. Clinical significance of isolated tumor cells and micrometastasis in low-grade, stage I endometrial cancer. J Surg Oncol. 2018 Dec;118(7):1194-1198. doi: 10.1002/jso.25259. Epub 2018 Oct 24.
PMID: 30353577RESULTPlante M, Stanleigh J, Renaud MC, Sebastianelli A, Grondin K, Gregoire J. Isolated tumor cells identified by sentinel lymph node mapping in endometrial cancer: Does adjuvant treatment matter? Gynecol Oncol. 2017 Aug;146(2):240-246. doi: 10.1016/j.ygyno.2017.05.024. Epub 2017 May 31.
PMID: 28577885RESULTGoebel EA, St Laurent JD, Nucci MR, Feltmate CM. Retrospective detection of isolated tumor cells by immunohistochemistry in sentinel lymph node biopsy performed for endometrial carcinoma: is there clinical significance? Int J Gynecol Cancer. 2020 Mar;30(3):291-298. doi: 10.1136/ijgc-2019-000934. Epub 2019 Dec 8.
PMID: 31818860RESULTAloisi A, Casanova JM, Tseng JH, Seader KA, Nguyen NT, Alektiar KM, Makker V, Chiang S, Soslow RA, Leitao MM Jr, Abu-Rustum NR. Patterns of FIRST recurrence of stage IIIC1 endometrial cancer with no PARAAORTIC nodal assessment. Gynecol Oncol. 2018 Dec;151(3):395-400. doi: 10.1016/j.ygyno.2018.09.021. Epub 2018 Oct 2.
PMID: 30286945RESULTNica A, Gien LT, Ferguson SE, Covens A. Does small volume metastatic lymph node disease affect long-term prognosis in early cervical cancer? Int J Gynecol Cancer. 2020 Mar;30(3):285-290. doi: 10.1136/ijgc-2019-000928. Epub 2019 Dec 22.
PMID: 31871114RESULTDelomenie M, Bonsang-Kitzis H, Bats AS, Ngo C, Balaya V, Xuan HTN, Koual M, Mathevet P, Lecuru F. The clinical implication of lymph nodes micrometastases and isolated tumor cells in patients with cervical cancer: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:71-76. doi: 10.1016/j.ejogrb.2019.08.010. Epub 2019 Aug 19.
PMID: 31450214RESULTGuani B, Dorez M, Magaud L, Buenerd A, Lecuru F, Mathevet P. Impact of micrometastasis or isolated tumor cells on recurrence and survival in patients with early cervical cancer: SENTICOL Trial. Int J Gynecol Cancer. 2019 Mar;29(3):447-452. doi: 10.1136/ijgc-2018-000089. Epub 2019 Jan 4.
PMID: 30833435RESULTCibula 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.
PMID: 22120175RESULTCibula 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.
PMID: 30318103RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Martinelli, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 27, 2020
Study Start
January 2, 2020
Primary Completion
January 1, 2025
Study Completion (Estimated)
January 1, 2027
Last Updated
August 17, 2022
Record last verified: 2022-08