Thyroid CancerNCT02778412
ctDNA in Patients With Thyroid Nodules
An observational study of Thyroid Cancer and Thyroid Nodules, run by Pathway Genomics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodules, Thyroid Adenoma
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 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.
Who cannot join
- Prior history of cancer excluding basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thyroid & Endocrine Center of Florida
Sarasota, Florida, 34239
About this study
Official title: Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Thyroid Cancer in Patients Undergoing Diagnostic Fine Needle Aspirations of the Thyroid
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).
Read the detailed description
After the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to the performance of the fine needle aspiration biopsy of the thyroid. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.
- Conditions
- Thyroid Cancer, Thyroid Nodules, Thyroid Adenoma, Thyroiditis
- Keywords
- Thyroid cancer, Thyroid nodules, Thyroid neoplasia, Thyroiditis
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule, Thyroiditis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.
Subjects will be contacted yearly to obtain follow-up information regarding the development of thyroid or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Preliminary results indicated that this test had a number of false-negative results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathway Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn D. Braunstein, M.D., Principal investigator, Pathway GenomicsAnja Kammesheidt, PhD, Principal investigator, Pathway Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778412
- Sponsor's protocol ID
- Pathway Genomics-007
- Status last verified
- Aug 2017
- First submitted
- 16 May 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The patient's physician will receive the results and the patients have the option to also receive the results.
Publications
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.
PubMed 23788690
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Thyroid Cancer in Patients Undergoing Diagnostic Fine Needle Aspirations of the Thyroid
- ClinicalTrials.gov ID
- NCT02778412
- Acronym / sponsor ID
- Pathway Genomics-007
- Conditions
- Thyroid Cancer, Thyroid Nodules, Thyroid Adenoma, Thyroiditis
- Keywords
- Thyroid cancer, Thyroid nodules, Thyroid neoplasia, Thyroiditis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary results indicated that this test had a number of false-negative results.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pathway GenomicsIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
After the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to the performance of the fine needle aspiration biopsy of the thyroid. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 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.
Key exclusion criteria (1 listed)
- Prior history of cancer excluding basal cell carcinoma of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Utility of plasma ctDNA measurements to detect thyroid cancer
Time frame: 1 year
Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.
Screening characteristics of ctDNA measurement in patients with and without thyroid cancer.
Time frame: 1 year
Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.
1 secondary outcome
Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Preliminary results indicated that this test had a number of false-negative results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Background: PubMed 23788690Pupilli 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.
- Individual participant dataSharing planned: Yes. The patient's physician will receive the results and the patients have the option to also receive the results.
Related trials for Thyroid Cancer
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
RecruitingObservational study
Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Non-Medullary Thyroid Cancer
RecruitingPhase 2
Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer
Differentiated Thyroid Carcinoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn D. Braunstein, M.D. principal investigator
Pathway Genomics
Anja Kammesheidt, PhD principal investigator
Pathway Genomics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Nodules, run by Pathway Genomics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Preliminary results indicated that this test had a number of false-negative results.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of plasma ctDNA measurements to detect thyroid cancer (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.