Computerized CytomorphometryNCT03105648
Diagnostic and Prognostic Significance of Computerized Cytologic Morphometry of the Thyroid Neoplasm
An observational study of Computerized Cytomorphometry, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The prevalence of thyroid nodule is worldwide high. About 40% of normal population has thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from benign nodules because the management is completely different. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Computerized Cytomorphometry
- What is being tested?
- computerized cytomorphometry
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2016to 20 Apr 2026
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who previously had received thyroid fine needle aspiration cytology examination
Who may be able to join
- patients who previously had received thyroid fine needle aspiration cytology examination
Who cannot join
- patients who are younger than 20 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chia-Chun Ho, +886-2-3366 ext. 8657, 112893@ntuh.gov.tw
About this study
The prevalence of thyroid nodule is worldwide high. About 40% of normal population has thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from benign nodules because the management is completely different. Nowadays, the gold standard is fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity is fair (~90%), but still has its limitation that some results are indeterminate in about 15% of the nodules. These obstacles are especially troublesome for papillary and follicular thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation. Preoperative evaluation of the prognosis is extraordinary important for cancer management. However, current prognostic scoring systems is only applicable after surgery. Hence, we urgently need a better risk-stratification system for individual-tailored treatment, and genetic-based computerized morphometry study seems to be the most realistic and promising one. The goal of this study is to propose a reliable method for diagnosis and prognosis of papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic characteristics.
- Conditions
- Computerized Cytomorphometry
- Being tested
- computerized cytomorphometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized cytomorphometryOther
use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination
| Study group | Role | What they receive |
|---|---|---|
| thyroid cancer | Not described Receives: Other: computerized cytomorphometry | |
| benign thyroid nodules | Not described Receives: Other: computerized cytomorphometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytomorphometry of the cells
cytologic characteristics of the cells
Measured: 2016/4/20-2026/4/20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Jul 2016
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computerized CytomorphometryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyang-Rong Shih, Ph.D., Principal investigator, National Taiwan University Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105648
- Sponsor's protocol ID
- 201603064RIPB
- Status last verified
- Feb 2021
- First submitted
- 4 Apr 2017
- Last updated
- 18 Feb 2021
- 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Significance of Computerized Cytologic Morphometry of the Thyroid Neoplasm
- ClinicalTrials.gov ID
- NCT03105648
- Acronym / sponsor ID
- 201603064RIPB
- Conditions
- Computerized Cytomorphometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 10 Apr 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 prevalence of thyroid nodule is worldwide high. About 40% of normal population has thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from benign nodules because the management is completely different. Nowadays, the gold standard is fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity is fair (~90%), but still has its limitation that some results are indeterminate in about 15% of the nodules. These obstacles are especially troublesome for papillary and follicular thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation. Preoperative evaluation of the prognosis is extraordinary important for cancer management. However, current prognostic scoring systems is only applicable after surgery. Hence, we urgently need a better risk-stratification system for individual-tailored treatment, and genetic-based computerized morphometry study seems to be the most realistic and promising one. The goal of this study is to propose a reliable method for diagnosis and prognosis of papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thyroid cancer | – | Other: computerized cytomorphometry |
| benign thyroid nodules | – | Other: computerized cytomorphometry |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who previously had received thyroid fine needle aspiration cytology examination
Key inclusion criteria (1 listed)
- patients who previously had received thyroid fine needle aspiration cytology examination
Key exclusion criteria (1 listed)
- patients who are younger than 20 years old
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 |
|---|---|---|
| computerized cytomorphometryuse computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination | Other | benign thyroid nodules, thyroid cancer |
Primary outcome
cytomorphometry of the cells
Time frame: 2016/4/20-2026/4/20
cytologic characteristics of the cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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.
Shyang-Rong Shih, Ph.D. principal investigator
National Taiwan University Hospita
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 Computerized Cytomorphometry, run by National Taiwan University Hospital at 1 site in Taiwan.
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 18 Feb 2021. 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 Taiwan. 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 Shyang-Rong Shih, Ph.D. (886-972653337, srshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytomorphometry of the cells (time frame: 2016/4/20-2026/4/20). 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 18 Feb 2021.