NCT01324609

Brief Summary

The purpose of this study is to determine if the investigators can detect the presence of choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and classification of choroidal nevi and melanomas in the future.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

March 25, 2011

Last Update Submit

July 7, 2020

Conditions

Nevus

Keywords

choroidal nevusvitrectomy

Outcome Measures

Primary Outcomes (1)

  • Positive identification of nevus cells in eye fluid

    1 day

Eligibility Criteria

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

Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication.

You may qualify if:

  • Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication (such as epiretinal membrane or macular hole repair).

You may not qualify if:

  • Patients without a choroidal nevus
  • Children under the age of 18
  • Pregnant and nursing females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Dr. Darius M. Moshfeghi

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 25, 2011

First Posted

March 29, 2011

Study Start

June 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

US(1)