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Multicenter Selective Lymphadenectomy Trial II (MSLT-II)

NCT00297895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1939

Last updated 2022-05-13

No results posted yet for this study

Summary

Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If the subject is sentinel node positive and meets study requirements, the subject is randomized to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound. Subjects are then followed for 10 years.

Conditions

Interventions

PROCEDURE

Completion Lymphadenectomy

complete lymph node dissection of lymph node basin with positive node

PROCEDURE

Monitoring with nodal ultrasound

serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Saint John's Cancer Institute

    lead OTHER

Principal Investigators

  • Richard Essner, M.D. · Saint John's Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States
  • Australia
  • Canada
  • Finland
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00297895 on ClinicalTrials.gov