NCT00955578

Brief Summary

The investigators' goal is to identify the mutation in the gene that is responsible for the development of segmental dysplastic nevi. To identify the gene the investigators may use a candidate gene approach (i.e. sequence specific genes that are thought to be involved: NRAS, BRAF, etc) or a genome-wide approach trying to implicate regions in the genome (Loss-of-heterozygosity or copy number changes on comparative genomic hybridization).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

August 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 21, 2024

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

August 7, 2009

Last Update Submit

August 19, 2024

Conditions

Study Arms (1)

Segmental Dysplastic Nevi

One patient who has been diagnosed with SDN and has had previous biopsies in the past, comparing to current biopsies

Procedure: Punch Biopsy

Interventions

Punch BiopsyPROCEDURE

5-6 punch biopsies of affected areas

Segmental Dysplastic Nevi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

One patient who is already known to the principal investigator

You may qualify if:

  • Patient with a positive history of segmental dysplastic nevi

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Heatlh

Halifax, Nova Scotia, B3H1V7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

The participant will be involved in the study for the length of time required to obtain 5 to 6 skin biopsiesThe laboratory testing that will be performed includes a genetic analysis of the tissue obtained from biopsy. The genetic analysis will take place in the genetics lab of Dr. Hensin Tsao, Massachusetts General Hospital, Bartlett 622, 48 Blossom Street, Boston MA, 02114.

Study Officials

  • Richard GB Langley, MD, FRCPC

    Capital Health/Dalhousie University

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 10, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

August 21, 2024

Record last verified: 2009-09

Locations