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

• Sponsor: University of Southern Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02825355
• Collaborator: Odense University Hospital (Other), Danish Cancer Society (Other)
• Enrollment: 512
• Locations: 3
• Actual Duration (Months): 62.1
• Patients Per Site: 170.7
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	Intervention/Treatment	Phase
Uterine Cervical Neoplasms; Uterine Neoplasms

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 512 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
• Actual Study Start Date: Feb 27, 2017
• Actual Primary Completion Date: May 1, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Incidence of lymphedema [3 years]

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

2. Severity of lymphedema [3 years]

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

Secondary Outcome Measures

1. Detection rate of sentinel lymph node [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 [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100
2	Herlev Hospital	Herlev		Denmark	2730
3	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• University of Southern Denmark
• Odense University Hospital
• Danish Cancer Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sara Sponholtz, MD, University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT02825355
• Other Study ID Numbers: SDUSF12015163 1 (198)
• First Posted: Jul 7, 2016
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sara Sponholtz, MD, University of Southern Denmark: robotic surgery procedure; indocyanine green; sentinel lymph node mapping
• Additional relevant MeSH terms: Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms

Study Results

No Results Posted as of May 24, 2022