Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

NCT ID: NCT02825355

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-27

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Cervical Neoplasms Uterine Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cervical cancer

All patients receive sentinel node mapping as the conventional treatment.

No interventions assigned to this group

Patients with endometrial cancer

All patients receive sentinel node mapping as the conventional treatment.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sara Sponholtz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Herlev Hospital

Herlev, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.

Reference Type DERIVED
PMID: 33829991 (View on PubMed)

Other Identifiers

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SDUSF12015163 1 (198)

Identifier Type: -

Identifier Source: org_study_id

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