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Completed

NCT Number: NCT02825355

Sentinel Node Mapping 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.

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Key information

Conditions

Uterine Cervical Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danish Cancer Society
  • Odense University Hospital

Registry information

Official study title

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

Acronym: SENTIREC I

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2016
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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