NCT01792492

Brief Summary

This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

July 8, 2011

Last Update Submit

March 28, 2016

Conditions

Thyroid NoduleThyroid NeoplasmsThyroid Cancer

Keywords

Thyroid NeoplasmsOptical DevicesSpectrum AnalysisThyroid diseases

Outcome Measures

Primary Outcomes (1)

  • Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules

    The objective is to assess a device called an optical probe for the differentiation of thyroid cancer from normal thyroid tissue, benign thyroid nodules or parathyroid glands, and the detection of thyroid cancer within lymph nodes using a hand-held spectroscope, compare the spectra from benign and malignant thyroid nodules and use this to discriminate benign from malignant nodules based on final histopathology or cytology as the gold standard.

    two years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary hospital setting Urban hospital

You may qualify if:

  • Subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid goiter with nodules.

You may not qualify if:

  • Subjects whose thyroid specimens have been put in formalin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Thyroid NoduleThyroid NeoplasmsThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Study Officials

  • Jennifer E Rosen, M.D. FACS

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 8, 2011

First Posted

February 15, 2013

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

November 1, 2015

Last Updated

March 29, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)