Thyroid NoduleNCT03170804
Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
An observational study of Thyroid Nodule and Thyroid Cancer, run by Aventura Hospital and Medical Center at 1 site in United States.
Trial summary
The purpose of this registry is to collect uniform genomics-centered data on patients with nodular thyroid disease and cancer in a prospective fashion. After initial clinical evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation and a needle biopsy of the thyroid (fine needle… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer, Thyroid Diseases
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 Jan 2020
- How long will I take part?
- 30 Days
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who were diagnosed with thyroid nodules will have a complete clinical and US evaluation. Thyroid nodule biopsy indication and FNA vs core biopsy choices will be made entirely on the clinical grounds, by the managing physicians. Thyroid nodule biopsies may be performed at a participating medical or surgical endocrinology office.
Who may be able to join
- Patients will be eligible for registry enrollment if they are undergoing thyroid nodule work-up.
Who cannot join
- Patients will not be eligible for registry enrollment if a work-up beyond clinical evaluation is not indicated.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Aventura Hospital and Medical Center
Aventura, Florida, 33180
Hilda Mahmoudi, MD, 305-682-7261, hilda.mahmoudi@hcahealthcare.com
About this study
Official title: Registry for Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
The purpose of this registry is to collect uniform genomics-centered data on patients with nodular thyroid disease and cancer in a prospective fashion. After initial clinical evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will be performed as per clinically determined indications. Standard surgical pathology will be processed and reported per the institutional policy and procedures. A molecular/genomic profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients undergoing thyroid nodule work-up may be enrolled. The registry will collect patient demographic and clinical data, cytopathology reports, and surgical pathology reports and slides (if/when a review is required).
Read the detailed description
This is an open-ended prospective registry. The patients who were diagnosed with thyroid nodules will have a complete clinical and US evaluation. Thyroid nodule biopsy indication and FNA vs core biopsy choices will be made entirely on the clinical grounds, by the managing physicians. Thyroid nodule biopsies may be performed at a participating medical or surgical endocrinology office. Following standard cytologic examination a molecular testing using Thyroseq will be performed.
The biopsy results will be categorized according to Bethesda scoring system. Category I is non-diagnostic FNA and will require a repeat FNA. Category II is benign cytology, categories III, IV and V are the indeterminate group, and category VI is malignant cytology. The FNA analysis of registry patients will be collected under six groups. Thyroseq molecular testing may be deferred if not felt needed following cytology.
- Cytology(benign) / Thyroseq(-)
- Cytology(benign) / Thyroseq(+)
- Cytology(indeterminate) / Thyroseq(-)
- Cytology(indeterminate) / Thyroseq(+)
- Cytology(Malignant) / Thyroseq(-)
- Cytology(Malignant) / Thyroseq(+). Thyroid operation indication and lobectomy vs total thyroidectomy choices will be made entirely on the clinical grounds, by the managing physicians. The routine histopathology will be processed and reported as per the institutional protocols. The molecular testing of the preoperatively biopsied and intraoperatively and postoperatively identified lesions will be performed, as indicated.
The registry is open to all interested physicians involved in thyroid patient care and interested in participating
- Conditions
- Thyroid Nodule, Thyroid Cancer, Thyroid Diseases, Thymic Carcinoma
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Diseases, Thymoma
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostic value of Thyroseq v2 molecular/genomic profiling
The purpose of this registry is to collect uniform data on patients with nodular thyroid disease and thyroid cancer in a prospective fashion. Data collected will primarily be analyzed for diagnostic and prognostic value of Thyroseq v2 molecular/genomic profiling.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Jan 2020 (estimated)
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.
- 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
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Aventura Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seza Gulec, MD, Principal investigator, Aventura Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170804
- Sponsor's protocol ID
- 20162786
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03170804
- Acronym / sponsor ID
- 20162786
- Conditions
- Thyroid Nodule, Thyroid Cancer, Thyroid Diseases, Thymic Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aventura Hospital and Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 31 May 2017 (actual)
- 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.
The purpose of this registry is to collect uniform genomics-centered data on patients with nodular thyroid disease and cancer in a prospective fashion. After initial clinical evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will be performed as per clinically determined indications. Standard surgical pathology will be processed and reported per the institutional policy and procedures. A molecular/genomic profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients undergoing thyroid nodule work-up may be enrolled. The registry will collect patient demographic and clinical data, cytopathology reports, and surgical pathology reports and slides (if/when a review is required).
Detailed description
This is an open-ended prospective registry. The patients who were diagnosed with thyroid nodules will have a complete clinical and US evaluation. Thyroid nodule biopsy indication and FNA vs core biopsy choices will be made entirely on the clinical grounds, by the managing physicians. Thyroid nodule biopsies may be performed at a participating medical or surgical endocrinology office. Following standard cytologic examination a molecular testing using Thyroseq will be performed.
The biopsy results will be categorized according to Bethesda scoring system. Category I is non-diagnostic FNA and will require a repeat FNA. Category II is benign cytology, categories III, IV and V are the indeterminate group, and category VI is malignant cytology. The FNA analysis of registry patients will be collected under six groups. Thyroseq molecular testing may be deferred if not felt needed following cytology.
- Cytology(benign) / Thyroseq(-)
- Cytology(benign) / Thyroseq(+)
- Cytology(indeterminate) / Thyroseq(-)
- Cytology(indeterminate) / Thyroseq(+)
- Cytology(Malignant) / Thyroseq(-)
- Cytology(Malignant) / Thyroseq(+). Thyroid operation indication and lobectomy vs total thyroidectomy choices will be made entirely on the clinical grounds, by the managing physicians. The routine histopathology will be processed and reported as per the institutional protocols. The molecular testing of the preoperatively biopsied and intraoperatively and postoperatively identified lesions will be performed, as indicated.
The registry is open to all interested physicians involved in thyroid patient care and interested in participating
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who were diagnosed with thyroid nodules will have a complete clinical and US evaluation. Thyroid nodule biopsy indication and FNA vs core biopsy choices will be made entirely on the clinical grounds, by the managing physicians. Thyroid nodule biopsies may be performed at a participating medical or surgical endocrinology office.
Key inclusion criteria (1 listed)
- Patients will be eligible for registry enrollment if they are undergoing thyroid nodule work-up.
Key exclusion criteria (1 listed)
- Patients will not be eligible for registry enrollment if a work-up beyond clinical evaluation is not indicated.
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
prognostic value of Thyroseq v2 molecular/genomic profiling
Time frame: an average of 1 year
The purpose of this registry is to collect uniform data on patients with nodular thyroid disease and thyroid cancer in a prospective fashion. Data collected will primarily be analyzed for diagnostic and prognostic value of Thyroseq v2 molecular/genomic profiling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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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.
Seza Gulec, MD principal investigator
Aventura Hospital and Medical Center
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 and Thyroid Cancer, run by Aventura Hospital and Medical Center 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 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: status not confirmed, as of the sponsor's last update on 31 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seza Gulec, MD (7866930821, sgulec@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognostic value of Thyroseq v2 molecular/genomic profiling (time frame: an average of 1 year). 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 31 May 2017.