Thyroid CancerPhase 2NCT02947035
Molecular Testing to Direct Extent of Initial Thyroid Surgery
A Phase 2 study testing Thyroid lobectomy and Total thyroidectomy with CCND in people with Thyroid Cancer, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Thyroid lobectomy and Total thyroidectomy with CCND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2017to 1 Jun 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Thyroid nodule is >1.5 cm
- Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer
Who cannot join
- Prior thyroid/parathyroid surgery
- Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when <18 years old
- Recurrent laryngeal nerve dysfunction
- Diagnosis of concurrent primary hyperparathyroidism
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.
Read the detailed description
The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.
- Conditions
- Thyroid Cancer
- Being tested
- Thyroid lobectomy, Total thyroidectomy with CCND
- Keywords
- thyroid cancer, thyroid nodule, thyroidectomy, personalized medicine
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid lobectomyProcedure or surgery
Thyroid lobectomy is removal of only part of the thyroid
Total thyroidectomy with CCNDProcedure or surgery
Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Low Risk | Experimental | Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy. Receives: Procedure: Thyroid lobectomy |
| High Risk | Experimental | Molecular testing and ultrasound features will be used to predict if thyroid cancer is high risk. Intervention will be to perform more aggressive surgery to include total thyroidectomy with CCND. Receives: Procedure: Total thyroidectomy with CCND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who require completion thyroidectomy for aggressive histology features
Histology characteristics of tumor will be assessed including type of cancer, extrathyroidal extension, lymph node metastasis, and margin status to assess if completion thyroidectomy is needed per the 2015 ATA guidelines
Measured: 2 years
Secondary outcomes (6)
Number of patients who had central compartment neck dissection but no lymph node metastasis were identified
Measured: 2 years
Number of patients with operative complications
incidence of permanent nerve injury, hypocalcemia, readmission
Measured: 2 years
Recurrence
Measured: >2 years
QOL metric - FACT-G cumulative score preop, postop, and at followup
Measured: 2 years
QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup
Measured: 2 years
QOL metric - SF36 cumulative score preop, postop, and at followup
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linwah Yip, University of Pittsburgh
- Investigators
- Linwah Yip, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947035
- Sponsor's protocol ID
- STUDY19050280
- Status last verified
- Jul 2023
- First submitted
- 20 Oct 2016
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Testing to Direct Extent of Initial Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02947035
- Acronym / sponsor ID
- STUDY19050280
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, thyroid nodule, thyroidectomy, personalized medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Oct 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.
The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.
Detailed description
The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk | Experimental | Procedure: Thyroid lobectomyMolecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy. |
| High Risk | Experimental | Procedure: Total thyroidectomy with CCNDMolecular testing and ultrasound features will be used to predict if thyroid cancer is high risk. Intervention will be to perform more aggressive surgery to include total thyroidectomy with CCND. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thyroid nodule is >1.5 cm
- Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer
Key exclusion criteria (4 listed)
- Prior thyroid/parathyroid surgery
- Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when <18 years old
- Recurrent laryngeal nerve dysfunction
- Diagnosis of concurrent primary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid lobectomyThyroid lobectomy is removal of only part of the thyroid | Procedure or surgery | Low Risk |
| Total thyroidectomy with CCNDTotal thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes | Procedure or surgery | High Risk |
Primary outcome
Number of patients who require completion thyroidectomy for aggressive histology features
Time frame: 2 years
Histology characteristics of tumor will be assessed including type of cancer, extrathyroidal extension, lymph node metastasis, and margin status to assess if completion thyroidectomy is needed per the 2015 ATA guidelines
6 secondary outcomes
Number of patients who had central compartment neck dissection but no lymph node metastasis were identified
Time frame: 2 years
Number of patients with operative complications
Time frame: 2 years
Recurrence
Time frame: >2 years
QOL metric - FACT-G cumulative score preop, postop, and at followup
Time frame: 2 years
QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup
Time frame: 2 years
QOL metric - SF36 cumulative score preop, postop, and at followup
Time frame: 2 years
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 14 Jul 2023.
- 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.
Linwah Yip, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thyroid lobectomy and Total thyroidectomy with CCND in people with Thyroid Cancer, run by University of Pittsburgh at 2 sites 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 4 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 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients who require completion thyroidectomy for aggressive histology features (time frame: 2 years). 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 14 Jul 2023.