Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

University of Southern Denmark512 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

512

Conditions

Uterine Cervical Neoplasms Uterine Neoplasms

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Rigshospitalet

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Incidence of lymphedema

Incidence of lymphedema will be assessed using patient reported outcome measures.

Time frame: 3 years

Severity of lymphedema

Severity of lymphedema will be assessed using patient reported outcome measures.

Time frame: 3 years

Secondary Outcomes

Detection rate of sentinel lymph node

Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally

Time frame: 2 years

Mapping of SLN in different types of lymph node stations

Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.