Thyroid Cancer, PapillaryNCT02952612
Active Surveillance of Papillary Thyroid Microcarcinoma
An observational study of Thyroid Cancer, Papillary, run by Dong Jun Lim at 1 site in South Korea.
Trial summary
Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Papillary
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This observational study enrolls patients who was diagnosed as papillary thyroid microcarcinoma by FNA (Fine needle aspiration) or CNA(Core needle aspiration) and who wish to be enrolled this study.
Who may be able to join
- < 1 cm solitary nodule
- Surrounded by ≥ 2 mm normal thyroid parenchyma
- Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery
- No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- No extrathyroidal extension
- Clinically N0 and Clinically M0
Show all 11Show fewer
- ≥ 18 years
- Combined severe comorbidities or Inoperable condition (optional)
- No wish to surgery and Willingness to accept active surveillance
- No history of radiotherapy on head and neck area
- Accepted by the Board of Thyroid Cancer Meeting
Who cannot join
- ≥ 1 cm nodule and multifocal nodules regardless of size
- Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer)
- Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- Extrathyroidal extension
- Any of N1 or M1
Show all 9Show fewer
- Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma
- < 18 years
- Not willing to accept observational active surveillance approach
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St Mary's Hospital
Seoul, Seocho-Gu, 137-701
Dong Jun Lim, MD,PhD, +82-2-2258-1220, ldj6026@catholic.ac.kr
Kwanhoon Jo, MD, 82-2-2258-1220, lovi@naver.com
About this study
Official title: Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center
Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach. The purpose of this study is to understand more about the characteristics of papillary microcarcinoma, which has been known for "the cancer slowly progression"
- Conditions
- Thyroid Cancer, Papillary
- Medical subject headings
- Thyroid Cancer, Papillary
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of papillary thyroid microcarcinoma
Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer, PapillaryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Jun Lim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Jun Lim, Seoul St. Mary's Hospital
- Investigators
- Dong-Jun Lim, MD, PhD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952612
- Sponsor's protocol ID
- KC16OISI0414
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center
- ClinicalTrials.gov ID
- NCT02952612
- Acronym / sponsor ID
- KC16OISI0414
- Conditions
- Thyroid Cancer, Papillary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dong Jun LimUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 2 Nov 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.
Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach. The purpose of this study is to understand more about the characteristics of papillary microcarcinoma, which has been known for "the cancer slowly progression"
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study enrolls patients who was diagnosed as papillary thyroid microcarcinoma by FNA (Fine needle aspiration) or CNA(Core needle aspiration) and who wish to be enrolled this study.
Key inclusion criteria (11 listed)
- < 1 cm solitary nodule
- Surrounded by ≥ 2 mm normal thyroid parenchyma
- Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery
- No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- No extrathyroidal extension
Key exclusion criteria (9 listed)
- ≥ 1 cm nodule and multifocal nodules regardless of size
- Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer)
- Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
- Extrathyroidal extension
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
Progression of papillary thyroid microcarcinoma
Time frame: 5 years after enrollment
Using thyroid sonography, check any changes in size and shape of papillary thyroid microcarcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Yes
Related trials for Thyroid Cancer, Papillary
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
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.
Dong-Jun Lim, MD, PhD study chair
Seoul St. Mary's Hospital
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 Cancer, Papillary, run by Dong Jun Lim at 1 site in South Korea.
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 11 inclusion and 9 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 8 Nov 2016. 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 South Korea. 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 Jeonghoon Ha, MD (+82-2-2258-6372, hajhoon@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of papillary thyroid microcarcinoma (time frame: 5 years after enrollment). 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 Nov 2016.