NCT02056522

Brief Summary

The use of MDS to access the presence of melanoma in the skin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 18, 2020

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

December 15, 2013

Last Update Submit

November 17, 2020

Conditions

Skin Lesions

Keywords

MelanomaSkin Cancer

Outcome Measures

Primary Outcomes (1)

  • To validate the performance of MDS

    28 days

Secondary Outcomes (1)

  • To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.

    28 days

Other Outcomes (1)

  • To further establish the safety of the MDS.

    28 days

Study Arms (1)

Suspicious skin lesions.

No intervention is administered.

Eligibility Criteria

Age21 Years - 97 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.

You may qualify if:

  • Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
  • The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
  • Male and female ≥ 21 years old.
  • Subject is capable of giving written informed consent.
  • Primary excision.

You may not qualify if:

  • The lesion is less than 1 cm from the eyes.
  • The lesion is on the palms of hands or soles of the feet.
  • Mucosal lesion.
  • Pregnant females.
  • Low study procedure compliance.
  • Patients who are mentally or physically unable to comply with all aspects of the study.
  • Undergoing chemotherapy.
  • Minor or legally incompetent and not able to sign the consent form.
  • Patient previously tested by MDS and was diagnosed with melanoma during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clalit Health Services

Kiryat Bialik, Israel

Location

Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shokrey Kassis, MA

    Head of Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2013

First Posted

February 6, 2014

Study Start

July 1, 2016

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

November 18, 2020

Record last verified: 2018-02

Locations

IL(2)