NCT01677975

Brief Summary

The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

First QC Date

August 30, 2012

Last Update Submit

August 31, 2012

Conditions

Melanoma

Study Arms (1)

ultrasound, dynamic lymphscintigraphy

EXPERIMENTAL
Procedure: FNA (fine needle aspiration)

Interventions

FNA (fine needle aspiration)PROCEDURE
ultrasound, dynamic lymphscintigraphy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2.

You may not qualify if:

  • Other malignant illness Known local, regional or non-regional metastasis on the time of diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ultrasounddepartment 4123, Rigshospitalet

Blegdamsvej 9, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Melanoma

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
afdelingslæge

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

September 1, 2012

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

DK(1)