Thyroid NoduleNCT02352766
Role of NGS-based ThyroSeq Panel in Cancer Diagnosis in Thyroid Nodules
An observational study of Thyroid Nodule, run by University of Pittsburgh at 1 site in United States.
Trial summary
Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow inexpensive testing for hundreds of mutational hotspots at the same time. A number of additional mutational markers in thyroid cancer have been identified. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 15 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that undergo a routine diagnostic thyroid FNA that consent in participating in the research study whose samples have indeterminate cytologic diagnosis (Bethesda III, VI, or V) and surgical outcome are submitted for molecular testing. (Sample will be given a code that de-identifies the sample before it is sent to the testing laboratory. The lab that will analyze specimens is a CLIA certified Pitt lab.)
Who may be able to join
- Patients that undergo a clinically diagnostic thyroid FNA
Who cannot join
- Children
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow inexpensive testing for hundreds of mutational hotspots at the same time. A number of additional mutational markers in thyroid cancer have been identified. Highly promising markers associated with tumor prognosis have also been found. This multi-institutional study aims to validate the diagnostic use of mutational markers in thyroid nodules with indeterminate cytology.
The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a large panel of mutational markers applied to thyroid FNA samples can provide an accurate cancer risk stratification in thyroid nodules.
The performance of the panel will be tested in a multi-institutional double-blind prospective study of FNA samples from thyroid nodules with indeterminate cytology and available surgical outcome
Read the detailed description
Thyroid cancer is the fifth most common cancer type in women and the fastest growing cancer diagnosis in the U.S. In 2013, an estimated 60,000 new cases were diagnosed. However, thyroid nodules are much more common, particularly in woman and with increased age. The prevalence of palpable nodules in population-based studies is 3-4% and the prevalence of non-palpable nodules incidentally identified on imaging approaches 40-50% after the age of 60. Thyroid cancer is the primary clinical concern in patient with thyroid nodules, although only small proportion (~5%) of thyroid nodules is malignant . The diagnosis of thyroid cancer relies on cervical ultrasound and fine needle aspiration (FNA) biopsy with cytologic examination. FNA cytology provides a definitive diagnosis of benign or malignant thyroid disease in most cases, although in approximately 30% of nodules, FNA cytology cannot reliably rule out cancer and such cases are reported as indeterminate for malignancy. Because of the lack of a definitive diagnosis, most patients with indeterminate cytology undergo diagnostic surgery to establish histopathologic diagnosis. However, only 20-30% of such surgically resected thyroid nodules will prove to be malignant. It has been estimated that ~150,000 thyroid surgeries are performed in the U.S. for benign nodules due to inability to rule out cancer without surgery. Additionally, an indeterminate preoperative diagnosis does not always lead to the optimal initial surgical intervention for patients who have thyroid cancer, as many of them undergo a two-step surgery, i.e. thyroid lobectomy followed by completion total thyroidectomy. Both unnecessary and two-step surgeries can be avoided with a more accurate preoperative diagnosis of cancer in thyroid nodules.
For patients who have signed an informed consent, the physician investigator will then perform a research needle wash. The syringe will be rinsed with a buffer solution to gather left over cells for the research sample. This FNA material will be collected for potential molecular testing into a collection tube that is stored at -20C.
The first five samples acquired will be processed irrespective of cytologic diagnosis to evaluate the collection technique.
Those samples that have indeterminate cytologic diagnosis (Bethesda III, VI, or V) and surgical outcome are submitted for molecular testing. (Sample will be given a code that de-identifies the sample before it is sent to the testing laboratory. The lab that will analyze specimens is a CLIA certified Pitt lab.)
Molecular analysis is performed at the Pitt lab without knowing surgical outcome.
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid cancer, Thyroid nodules, Palpable nodules, FNA
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine FNA for thyroid nodules | Patients that undergo a clinically diagnostic thyroid FNA will be asked by their clinician, who is a study co-investigator, if they are interested in participating in the research study. A small part of FNA material will be collected for molecular analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes
The primary outcome measured in this study is the performance (sensitivity, specificity, NPV, PPV) of the Thyroseq Panel in diagnosing cancer in thyroid nodules with Bethesda III, VI and V cytology.
Measured: April 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Johns Hopkins University, Ohio State University, University of Cincinnati, University of Colorado, Denver, University of Pennsylvania, University of Wisconsin, Madison, Medstar Health Research Institute
- Responsible party
- Principal investigator, Yuri Nikiforov, University of Pittsburgh
- Investigators
- Yuri Nikiforov, PhD, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352766
- Sponsor's protocol ID
- PRO14040164
- Other IDs
- PITT 9006477
- Status last verified
- Jul 2019
- First submitted
- 28 Jan 2015
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of NGS-based ThyroSeq Panel in Cancer Diagnosis in Thyroid Nodules
- ClinicalTrials.gov ID
- NCT02352766
- Acronym / sponsor ID
- PRO14040164
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid cancer, Thyroid nodules, Palpable nodules, FNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Duke University, Johns Hopkins University, Ohio State University, University of Cincinnati, University of Colorado, Denver, University of Pennsylvania, University of Wisconsin, Madison, Medstar Health Research Institute
- Study start
- Jan 2015
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 2 Feb 2015 (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.
Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow inexpensive testing for hundreds of mutational hotspots at the same time. A number of additional mutational markers in thyroid cancer have been identified. Highly promising markers associated with tumor prognosis have also been found. This multi-institutional study aims to validate the diagnostic use of mutational markers in thyroid nodules with indeterminate cytology.
The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a large panel of mutational markers applied to thyroid FNA samples can provide an accurate cancer risk stratification in thyroid nodules.
The performance of the panel will be tested in a multi-institutional double-blind prospective study of FNA samples from thyroid nodules with indeterminate cytology and available surgical outcome
Detailed description
Thyroid cancer is the fifth most common cancer type in women and the fastest growing cancer diagnosis in the U.S. In 2013, an estimated 60,000 new cases were diagnosed. However, thyroid nodules are much more common, particularly in woman and with increased age. The prevalence of palpable nodules in population-based studies is 3-4% and the prevalence of non-palpable nodules incidentally identified on imaging approaches 40-50% after the age of 60. Thyroid cancer is the primary clinical concern in patient with thyroid nodules, although only small proportion (~5%) of thyroid nodules is malignant . The diagnosis of thyroid cancer relies on cervical ultrasound and fine needle aspiration (FNA) biopsy with cytologic examination. FNA cytology provides a definitive diagnosis of benign or malignant thyroid disease in most cases, although in approximately 30% of nodules, FNA cytology cannot reliably rule out cancer and such cases are reported as indeterminate for malignancy. Because of the lack of a definitive diagnosis, most patients with indeterminate cytology undergo diagnostic surgery to establish histopathologic diagnosis. However, only 20-30% of such surgically resected thyroid nodules will prove to be malignant. It has been estimated that ~150,000 thyroid surgeries are performed in the U.S. for benign nodules due to inability to rule out cancer without surgery. Additionally, an indeterminate preoperative diagnosis does not always lead to the optimal initial surgical intervention for patients who have thyroid cancer, as many of them undergo a two-step surgery, i.e. thyroid lobectomy followed by completion total thyroidectomy. Both unnecessary and two-step surgeries can be avoided with a more accurate preoperative diagnosis of cancer in thyroid nodules.
For patients who have signed an informed consent, the physician investigator will then perform a research needle wash. The syringe will be rinsed with a buffer solution to gather left over cells for the research sample. This FNA material will be collected for potential molecular testing into a collection tube that is stored at -20C.
The first five samples acquired will be processed irrespective of cytologic diagnosis to evaluate the collection technique.
Those samples that have indeterminate cytologic diagnosis (Bethesda III, VI, or V) and surgical outcome are submitted for molecular testing. (Sample will be given a code that de-identifies the sample before it is sent to the testing laboratory. The lab that will analyze specimens is a CLIA certified Pitt lab.)
Molecular analysis is performed at the Pitt lab without knowing surgical outcome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine FNA for thyroid nodules | – | –Patients that undergo a clinically diagnostic thyroid FNA will be asked by their clinician, who is a study co-investigator, if they are interested in participating in the research study. A small part of FNA material will be collected for molecular analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that undergo a routine diagnostic thyroid FNA that consent in participating in the research study whose samples have indeterminate cytologic diagnosis (Bethesda III, VI, or V) and surgical outcome are submitted for molecular testing. (Sample will be given a code that de-identifies the sample before it is sent to the testing laboratory. The lab that will analyze specimens is a CLIA certified Pitt lab.)
Key inclusion criteria (1 listed)
- Patients that undergo a clinically diagnostic thyroid FNA
Key exclusion criteria (2 listed)
- Children
- pregnant women
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
Primary outcomes
Time frame: April 2016
The primary outcome measured in this study is the performance (sensitivity, specificity, NPV, PPV) of the Thyroseq Panel in diagnosing cancer in thyroid nodules with Bethesda III, VI and V cytology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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.
Yuri Nikiforov, PhD, MD principal investigator
University of Pittsburgh
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 Nodule, run by University of Pittsburgh 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcomes (time frame: April 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019.