Thyroid NoduleNCT04477798
Protein Classifier for Thyroid Indeterminate Nodules
A study testing PCT-DIA/MS in people with Thyroid Nodule, run by Luo Dingcun at 1 site in China.
Trial summary
In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- PCT-DIA/MS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Dec 2021
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aged 18 to 70 years old;
- Patients with thyroid nodules who have not been treated with drugs;
- Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
- Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
- Patients voluntarily participate in the study after informed consent.
Who cannot join
- Patients without operation;
- Patients with insufficient FNA sample size (judged by the laboratory).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College
Hangzhou, Zhejiang, 317500
Dingcun Luo
About this study
Official title: Protein Classifier for Thyroid Indeterminate Nodules： a Multi-center Prospective Clinical Study
In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.
- Conditions
- Thyroid Nodule
- Being tested
- PCT-DIA/MS
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT-DIA/MSDiagnostic test
PCT-DIA/MS will be validated to classify FNA biopsy specimens
| Study group | Role | What they receive |
|---|---|---|
| PCT-DIA/MS | Experimental | PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules Receives: Diagnostic Test: PCT-DIA/MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein classifier
classify thyroid indeterminate nodules as Benign or Malignant
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luo Dingcun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luo Dingcun, Zhejiang University
- Investigators
- Dingcun Luo, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477798
- Sponsor's protocol ID
- ZhejiangU20200701
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- 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 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Classifier for Thyroid Indeterminate Nodules： a Multi-center Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04477798
- Acronym / sponsor ID
- ZhejiangU20200701
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Luo DingcunUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jul 2020 (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.
In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCT-DIA/MS | Experimental | Diagnostic Test: PCT-DIA/MSPCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with aged 18 to 70 years old;
- Patients with thyroid nodules who have not been treated with drugs;
- Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
- Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
- Patients voluntarily participate in the study after informed consent.
Key exclusion criteria (2 listed)
- Patients without operation;
- Patients with insufficient FNA sample size (judged by the laboratory).
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 |
|---|---|---|
| PCT-DIA/MSPCT-DIA/MS will be validated to classify FNA biopsy specimens | Diagnostic test | PCT-DIA/MS |
Primary outcome
protein classifier
Time frame: immediately after the procedure
classify thyroid indeterminate nodules as Benign or Malignant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- 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.
Dingcun Luo principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCT-DIA/MS in people with Thyroid Nodule, run by Luo Dingcun at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Jul 2020. 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 China. 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 Dingcun Luo (+86057156005600, wlsydxjk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
protein classifier (time frame: immediately after the procedure). 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 20 Jul 2020.