Papillary MicrocarcinomaNCT02363595
Genomic Predictors of Papillary Microcarcinoma Disease Progression
An observational study of Papillary Microcarcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic? Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Microcarcinoma
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2014to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All papillary thyroid cancer patients evaluated at MSKCC clinic.
Who may be able to join
- Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist.
- Being followed with active surveillance at MSKCC
- Biopsied index nodule less than or equal to 2 cm in maximum dimension
- Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.
Who cannot join
- Biopsied index nodule greater than 2 cm in any dimension
- Age less than 18 yrs old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Tuttle, MD contact
Michael Berger, PhD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Robert Tuttle, MD, 646-888-2716
Michael Berger, PhD, 646-888-3386
About this study
The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic?
Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.
- Conditions
- Papillary Microcarcinoma
- Keywords
- Genomic Predictors, 14-277
- Medical subject headings
- Papillary Thyroid Microcarcinoma
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 |
|---|---|---|
| Papillary Microcarcinoma | This clinical trial protocol describes implementation of a prospective observation protocol to standardize data collection and obtain permission to collect samples of PMC tumors in a cohort of PMC patients being followed with active surveillance. This will allow PMC tumors to be accurately classified as either stable or progressive over time and used for comprehensive molecular profiling if surgical removal is required during follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the disease progression rate
Therefore, in order to ensure that we will have at least 459 patients with PTC being followed with active surveillance, we plan to enroll 500 total patients, of which 350 will have FNA diagnostic for PTC (of which 99% are expected to have PTC) and 150 patients will have FNA suspicious for PTC (of which 113 would be expected to have PTC). This sample size will enable us to estimate the 5 year disease progression rate requiring intervention to within ±4% at 95% confidence level (using binomial calculation under the assumption that the study is not stopped early and the progression rate is not higher than 10%).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study start31 Dec 2014
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary MicrocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Robert Tuttle, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363595
- Sponsor's protocol ID
- 14-277
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2015
- Last updated
- 12 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Predictors of Papillary Microcarcinoma Disease Progression
- ClinicalTrials.gov ID
- NCT02363595
- Acronym / sponsor ID
- 14-277
- Conditions
- Papillary Microcarcinoma
- Keywords
- Genomic Predictors, 14-277
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Ohio State University, University of Pittsburgh
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 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.
The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic?
Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Papillary Microcarcinoma | – | –This clinical trial protocol describes implementation of a prospective observation protocol to standardize data collection and obtain permission to collect samples of PMC tumors in a cohort of PMC patients being followed with active surveillance. This will allow PMC tumors to be accurately classified as either stable or progressive over time and used for comprehensive molecular profiling if surgical removal is required during follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All papillary thyroid cancer patients evaluated at MSKCC clinic.
Key inclusion criteria (4 listed)
- Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist.
- Being followed with active surveillance at MSKCC
- Biopsied index nodule less than or equal to 2 cm in maximum dimension
- Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.
Key exclusion criteria (2 listed)
- Biopsied index nodule greater than 2 cm in any dimension
- Age less than 18 yrs old
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
estimate the disease progression rate
Time frame: 4 years
Therefore, in order to ensure that we will have at least 459 patients with PTC being followed with active surveillance, we plan to enroll 500 total patients, of which 350 will have FNA diagnostic for PTC (of which 99% are expected to have PTC) and 150 patients will have FNA suspicious for PTC (of which 113 would be expected to have PTC). This sample size will enable us to estimate the 5 year disease progression rate requiring intervention to within ±4% at 95% confidence level (using binomial calculation under the assumption that the study is not stopped early and the progression rate is not higher than 10%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Papillary Microcarcinoma
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Laser Ablation of Papillary Thyroid Microcarcinoma
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RFA Treatment for Papillary Thyroid Microcarcinoma
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Not yet recruiting
Decision Aid Efficacy in Low Risk Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma
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Active Surveillance and Surgery Outcomes in Low Risk Papillary Thyroid Cancer
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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.
Robert Tuttle, MD contact
Michael Berger, PhD contact
Robert Tuttle, MD principal investigator
Memorial Sloan Kettering Cancer 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 Papillary Microcarcinoma, run by Memorial Sloan Kettering Cancer 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 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Tuttle, MD (646-888-2716), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimate the disease progression rate (time frame: 4 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 12 Mar 2026.