NCT00598364

Brief Summary

The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
847

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Typical duration 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

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3.7 years

First QC Date

January 10, 2008

Last Update Submit

December 5, 2014

Conditions

Thyroid Cancer

Keywords

thyroidnodulegeneticmutationmalignancy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is histologic lesion (benign (Graves, Hashimoto's, follicular adenoma or subtype of malignant lesion).

    7 years

Secondary Outcomes (1)

  • The main secondary outcome to be measured in malignant lesions includes measures of biologic behavior of malignant lesions including capsular and angiolymphatic invasion, local invasion and lymph node metastases at presentation

    7 years

Study Arms (1)

Thyroidectomy or neck dissection

Patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care.

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care.

You may qualify if:

  • Age 1 - 100
  • Benign or malignant thyroid lesion, other malignancy or no thyroid abnormality
  • Pathologic specimen available for analysis
  • Ability to provide informed consent (for prospective study, Part Two)
  • Age greater than age 18 (for normal controls)

You may not qualify if:

  • Patients without adequate data for analysis
  • Histopathologic or cytopathologic diagnosis of for medullary thyroid carcinoma (not derived from the thyroid follicular epithelium), thyroid lymphoma
  • Unwilling to participate or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid DiseasesNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System Diseases

Study Officials

  • Kathryn G. Schuff, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
13 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 21, 2008

Study Start

February 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

US(1)