Papillary Thyroid MicrocarcinomaPMCASNCT02609685
Active Surveillance of Papillary Thyroid Microcarcinoma
A study testing Active Surveillance in people with Papillary Thyroid Microcarcinoma, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Microcarcinoma
- What is being tested?
- Active Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2016to Dec 2030
- Phase
- Interventional
- 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
Who may be able to join
- Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation.
- 2.0 cm or smaller nodules by ultrasonographic criteria
- Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form
- Must be able to read and write English fluently to participate in the questionnaire portion of the study
Who cannot join
- High-grade or poorly differentiated PTC variants
- Central or lateral neck lymphadenopathy suspicious for PTC
- Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion)
- History of radiation to neck
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials Navigator contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Allen Ho, MD, 310-423-1220, Allen.Ho@cshs.org
Allen Ho, MD
About this study
The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.
Read the detailed description
The incidence of thyroid cancer has more than doubled in the last 30 years in the United States, Europe, Canada, and South America. Since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (PTMC), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise.
The primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of PTMC patients followed with active surveillance in the United States.
Patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. Patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.
- Conditions
- Papillary Thyroid Microcarcinoma
- Being tested
- Active Surveillance
- Keywords
- Thyroid cancer, Active surveillance, PTMC
- Medical subject headings
- Papillary Thyroid Microcarcinoma, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceOther
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Other | Active surveillance instead of standard of care immediate surgery. Patients will be closely monitored every six months until disease is stable for a two-year period and then annually thereafter. Receives: Other: Active Surveillance |
| Immediate Surgery | No intervention | Patients who choose to get surgery immediately after diagnosis may choose to enroll in a questionnaire sub-study that will compare quality of life and anxiety scores to patients who enroll in the active surveillance study. This is considered "no intervention" because the protocol is not directing treatment. Surgery is the standard treatment for papillary thyroid microcarcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disease progression
Measured: From time of diagnosis up to10 years of follow-up
Secondary outcomes (6)
Percentage of subjects that will elect surgery despite absence of clinical progression
Measured: From time of diagnosis up to 10 years of follow-up
Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound
Measured: Five years
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
Measured: Five years
Identify the genetic factors associated with an increased risk of disease progression
At any time subjects who have enrolled in the active surveillance study can opt to have surgery. Data will be taken from diagnosis to just after surgery.
Measured: Five years
Quality of life score as measured by City of Hope Quality of Life Scale
Measured: Up to five years
Anxiety score as measured by Memorial Anxiety Scale
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start13 May 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
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 Papillary Thyroid MicrocarcinomaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allen Ho, Cedars-Sinai Medical Center
- Investigators
- Allen Ho, MD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609685
- Sponsor's protocol ID
- IIT2014-13-Ho-PMCAS
- Acronym
- PMCAS
- Status last verified
- Nov 2026
- First submitted
- 18 Nov 2015
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ho AS, Kim S, Zalt C, Melany ML, Chen IE, Vasquez J, Mallen-St Clair J, Chen MM, Vasquez M, Fan X, van Deen WK, Haile RW, Daskivich TJ, Zumsteg ZS, Braunstein GD, Sacks WL. Expanded Parameters in Active Surveillance for Low-risk Papillary Thyroid Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2022 Sep 15;8(11):1588-96. doi: 10.1001/jamaoncol.2022.3875. Online ahead of print.
PubMed 36107411
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance of Papillary Thyroid Microcarcinoma
- ClinicalTrials.gov ID
- NCT02609685
- Acronym / sponsor ID
- PMCAS / IIT2014-13-Ho-PMCAS
- Conditions
- Papillary Thyroid Microcarcinoma
- Keywords
- Thyroid cancer, Active surveillance, PTMC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 13 May 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Nov 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 purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.
Detailed description
The incidence of thyroid cancer has more than doubled in the last 30 years in the United States, Europe, Canada, and South America. Since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (PTMC), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise.
The primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of PTMC patients followed with active surveillance in the United States.
Patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. Patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Other | Other: Active SurveillanceActive surveillance instead of standard of care immediate surgery. Patients will be closely monitored every six months until disease is stable for a two-year period and then annually thereafter. |
| Immediate Surgery | No intervention | –Patients who choose to get surgery immediately after diagnosis may choose to enroll in a questionnaire sub-study that will compare quality of life and anxiety scores to patients who enroll in the active surveillance study. This is considered "no intervention" because the protocol is not directing treatment. Surgery is the standard treatment for papillary thyroid microcarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation.
- 2.0 cm or smaller nodules by ultrasonographic criteria
- Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form
- Must be able to read and write English fluently to participate in the questionnaire portion of the study
Key exclusion criteria (4 listed)
- High-grade or poorly differentiated PTC variants
- Central or lateral neck lymphadenopathy suspicious for PTC
- Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion)
- History of radiation to neck
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 |
|---|---|---|
| Active SurveillanceSubjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care. | Other | Active Surveillance |
Primary outcome
Rate of disease progression
Time frame: From time of diagnosis up to10 years of follow-up
6 secondary outcomes
Percentage of subjects that will elect surgery despite absence of clinical progression
Time frame: From time of diagnosis up to 10 years of follow-up
Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound
Time frame: Five years
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
Time frame: Five years
Identify the genetic factors associated with an increased risk of disease progression
Time frame: Five years
Quality of life score as measured by City of Hope Quality of Life Scale
Time frame: Up to five years
Anxiety score as measured by Memorial Anxiety Scale
Time frame: Up to five years
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 4 Nov 2026.
- Derived from this study: PubMed 36107411Ho AS, Kim S, Zalt C, Melany ML, Chen IE, Vasquez J, Mallen-St Clair J, Chen MM, Vasquez M, Fan X, van Deen WK, Haile RW, Daskivich TJ, Zumsteg ZS, Braunstein GD, Sacks WL. Expanded Parameters in Active Surveillance for Low-risk Papillary Thyroid Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2022 Sep 15;8(11):1588-96. doi: 10.1001/jamaoncol.2022.3875. Online ahead of print.
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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.
Clinical Trials Navigator contact
Allen Ho, MD principal investigator
Cedars-Sinal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Surveillance in people with Papillary Thyroid Microcarcinoma, run by Cedars-Sinai 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 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 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 Allen Ho, MD (310-423-1220, Allen.Ho@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disease progression (time frame: From time of diagnosis up to10 years of follow-up). 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 NCT02609685, 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 4 Nov 2026.