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

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ClinicalTrials.gov Identifier: NCT02825355
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Odense University Hospital
Danish Cancer Society
Information provided by (Responsible Party):
Sara Sponholtz, University of Southern Denmark

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.

Condition or disease
Uterine Cervical Neoplasms Uterine Neoplasms

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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.



Primary Outcome Measures :
  1. Incidence of lymphedema [ Time Frame: 3 years ]
    Incidence of lymphedema will be assessed using patient reported outcome measures.

  2. Severity of lymphedema [ Time Frame: 3 years ]
    Severity of lymphedema will be assessed using patient reported outcome measures.


Secondary Outcome Measures :
  1. Detection rate of sentinel lymph node [ Time Frame: 2 years ]
    Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
See above in eligibility criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825355


Contacts
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Contact: Sara E Sponholtz, MD + 45 28439977 sara.elisabeth.sponholtz2@rsyd.dk

Locations
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Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Sara E Sponholtz, MD    +45 28439977    Sara.Elisabeth.Sponholtz@rsyd.dk   
Herlev Hospital Not yet recruiting
Herlev, Denmark, 2730
Contact: Sara E Sponholtz, MD    +45 28439977    Sara.Elisabeth.Sponholtz@rsyd.dk   
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Sara E Sponholtz, MD    +45 28439977    Sara.Elisabeth.Sponholtz@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Danish Cancer Society

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Responsible Party: Sara Sponholtz, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02825355     History of Changes
Other Study ID Numbers: SDUSF12015163 1 (198)
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Sponholtz, University of Southern Denmark:
robotic surgery procedure
indocyanine green
sentinel lymph node mapping

Additional relevant MeSH terms:
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Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases