Sentinel Node Mapping in Women With Cervical and Endometrial Cancer (SENTIREC I)

May 23, 2022 updated by: Sara Sponholtz, University of Southern Denmark

Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

512

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

See above in eligibility criteria.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lymphedema
Time Frame: 3 years
Incidence of lymphedema will be assessed using patient reported outcome measures.
3 years
Severity of lymphedema
Time Frame: 3 years
Severity of lymphedema will be assessed using patient reported outcome measures.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of sentinel lymph node
Time Frame: 2 years
Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally
2 years
Mapping of SLN in different types of lymph node stations
Time Frame: 2 years
Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Danish Cancer Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDUSF12015163 1 (198)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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