NCT00540566

Brief Summary

This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 1999

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

9 years

First QC Date

October 4, 2007

Last Update Submit

October 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • normal skin

    12 weeks

Study Arms (1)

Optical Biopsy

Optical Biopsy imaging

Device: Optical Biopsy imaging

Interventions

Optical Biopsy imaging

Optical Biopsy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic, community sample

You may qualify if:

  • Male or female age \> 18 years

You may not qualify if:

  • current participation in any other investigational drug evaluation
  • inability to understand and carry out instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute, Unversity of California Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

MelanomaCarcinoma, Merkel CellCarcinoma, Basal CellCarcinoma, Squamous CellDysplastic Nevus SyndromeKeratosis, SeborrheicOsteitis DeformansHistiocytoma, Benign FibrousSarcoma, KaposiPort-Wine StainHemangiomaScleroderma, DiffuseBurns

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesPolyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal CellNeoplasms, Squamous CellNevusNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesKeratosisBone DiseasesMusculoskeletal DiseasesHistiocytomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueHerpesviridae InfectionsSarcomaNeoplasms, Vascular TissueSkin AbnormalitiesCongenital AbnormalitiesScleroderma, SystemicConnective Tissue DiseasesWounds and Injuries

Study Officials

  • John S Nelson, M.D,Ph.D

    Beckman Laser Institue, University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

June 1, 1999

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations