Sentinel Node Mapping in Women With Cervical and Endometrial Cancer
SENTIREC I
Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
1 other identifier
observational
512
1 country
3
Brief Summary
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
3 active sites
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
First Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedStudy Start
First participant enrolled
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 24, 2022
May 1, 2022
5.2 years
June 23, 2016
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of lymphedema
Incidence of lymphedema will be assessed using patient reported outcome measures.
3 years
Severity of lymphedema
Severity of lymphedema will be assessed using patient reported outcome measures.
3 years
Secondary Outcomes (2)
Detection rate of sentinel lymph node
2 years
Mapping of SLN in different types of lymph node stations
2 years
Study Arms (2)
Patients with cervical cancer
All patients receive sentinel node mapping as the conventional treatment.
Patients with endometrial cancer
All patients receive sentinel node mapping as the conventional treatment.
Eligibility Criteria
See above in eligibility criteria.
You may qualify if:
- Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size \< 2 cm
- Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, \> 50% myometrial invasion
You may not qualify if:
- Prior PL
- Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- Women included in other studies affecting outcome-measures of the present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Odense University Hospitalcollaborator
- Danish Cancer Societycollaborator
Study Sites (3)
Rigshospitalet
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
Related Publications (1)
Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
PMID: 33829991DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 23, 2016
First Posted
July 7, 2016
Study Start
February 27, 2017
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
May 24, 2022
Record last verified: 2022-05