NCT02778412

Brief Summary

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test can detect a cancer at a very early stage. The results of this study should help define the role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign thyroid nodules).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

May 16, 2016

Last Update Submit

August 16, 2017

Conditions

Thyroid CancerThyroid NodulesThyroid AdenomaThyroiditis

Keywords

Thyroid cancerThyroid nodulesThyroid neoplasiaThyroiditis

Outcome Measures

Primary Outcomes (2)

  • Utility of plasma ctDNA measurements to detect thyroid cancer

    Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.

    1 year

  • Screening characteristics of ctDNA measurement in patients with and without thyroid cancer.

    Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.

    1 year

Secondary Outcomes (1)

  • Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.

    5 years

Eligibility Criteria

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

Individuals 18 year of age or older without a prior diagnosis of cancer who are going to undergo a fine needle aspiration biopsy of the thyroid gland as part of their standard care.

You may qualify if:

  • years of age or older;
  • presence of one or more thyroid nodules who are going to have a fine needle aspiration biopsy performed as part of their normal care.

You may not qualify if:

  • Prior history of cancer excluding basal cell carcinoma of the skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thyroid & Endocrine Center of Florida

Sarasota, Florida, 34239, United States

Location

Related Publications (1)

  • Pupilli C, Pinzani P, Salvianti F, Fibbi B, Rossi M, Petrone L, Perigli G, De Feo ML, Vezzosi V, Pazzagli M, Orlando C, Forti G. Circulating BRAFV600E in the diagnosis and follow-up of differentiated papillary thyroid carcinoma. J Clin Endocrinol Metab. 2013 Aug;98(8):3359-65. doi: 10.1210/jc.2013-1072. Epub 2013 Jun 20.

    PMID: 23788690BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood is drawn and DNA is purified from the plasma. The DNA is analyzed for circulating tumor DNA. The DNA will be stored for up to 10 years with the patient's permission.

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid NoduleThyroiditis

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Glenn D. Braunstein, M.D.

    Pathway Genomics

    PRINCIPAL INVESTIGATOR

  • Anja Kammesheidt, PhD

    Pathway Genomics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 19, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

The patient's physician will receive the results and the patients have the option to also receive the results.

Locations

US(1)