Thyroid CancerNCT04948437
Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of Thyroid Cancer
An observational study of Thyroid Cancer and Papillary Thyroid Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Now, the investigators carried out a prospective study enrolling patients with thyroid cancer, who had received ablative thyroidectomy and /or radioactive iodine therapy for two more years. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thyroid Cancer, Papillary Thyroid Cancer, Follicular Thyroid Cancer
- How many people
- 103 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2021to 31 Oct 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators carried out a prospective study enrolling patients with thyroid cancer, who had received ablative thyroidectomy and /or radioactive iodine therapy for two more years. The study already enrolled seventy-three patients with thyroid cancer, and the investigators plan to enroll 30 new patients in this consecutive research study. All patients received total thyroidectomy under clinically surgical judgement in initial therapeutic option. The investigators also further found some difference between papillary thyroid cancer and follicular thyroid cancer, and we will continue annually to closely monitor the change of U-Ex Tg and urinary exosomal galectin-3 between differently cellular types of thyroid cancers.
Who may be able to join
- diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer, post-operation follow up
Who cannot join
- unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of Well-differentiated Thyroid Cancer
Now, the investigators carried out a prospective study enrolling patients with thyroid cancer, who had received ablative thyroidectomy and /or radioactive iodine therapy for two more years. The investigators' study already enrolled seventy-three patients with thyroid cancer, and the investigators plan to enroll 30 new patients in this consecutive research study. All patients received total thyroidectomy under clinically surgical judgement in initial therapeutic option. The investigators also further found some difference between papillary thyroid cancer and follicular thyroid cancer, and the investigators will continue annually to closely monitor the change of U-Ex Tg and urinary exosomal galectin-3 between differently cellular types of thyroid cancers.
Read the detailed description
Although, most thyroid cancers are clinically endocrine tumors of low malignancy, most patients usually receive radioactive iodine-131 treatment and thyroidectomy. Such patients are followed up with thyroid ultrasound and continuous serum thyroglobulin assessment after surgery. Previous studies have shown that one third of well-differentiated thyroid cancers may be transformed into poorly differentiated or even fatal malignant tumors during disease progression, but the efficacy of surgery, chemotherapy and external radiation therapy is not significant. . In other words, effective treatment strategies and tracking models will be very important, including surgical removal of thyroid cancer, radioactive iodine-131 treatment, and tracking of biomarkers in thyroid cancer.
When thyroid cancer cells are poorly differentiated, cell dedifferentiation is a key factor for malignant transformation and invasion. Usually in papillary thyroid carcinoma and follicular thyroid carcinoma, the cancer cells will gradually dedifferentiate, and undifferentiated thyroid carcinoma is the final result. Therefore, the investigators try to find biomarkers and therapeutic tracking targets based on the expression of exosomal proteins in urine. The basis of this clinical study depends on the previous basic experiments of culturing undifferentiated thyroid cancer cells.
Exosomes are nanosomes that are secreted into the extracellular environment. Cancer cell-derived exosomes can be found in the plasma, saliva, urine and other body fluids of cancer patients. The investigators will analyze exosomal proteins in urine, including thyroglobulin and galectin-3, and discover early prognostic biomarkers in urine through the prospectively observation study. The investigators have published preliminary research papers on 16 patients with thyroid mastoid carcinoma and follicular carcinoma in international scientific journals. During the period of surgery and further radioactive iodine-131 therapy, including before and one day after surgery, 3 months and 6 months after surgery, the urinary biomarkers of thyroglobulin and galectin-3 in the urine were analyzed at different stages . A prospective study currently in progress has enrolled 73 patients with thyroid mastoid carcinoma and follicular carcinoma. After thyroidectomy, urine was collected during outpatient follow-up and analyzed for exosome biomarkers in the urine. During the first two years of this project, such new urinary biomarkers of thyroid papillary carcinoma and thyroid follicular carcinoma had shown certain different patterns. The investigators' research team expects to enroll 30 new thyroid cancer patients in this consecutive plan. Under continuous follow-up research, in addition to identifying the clinical application of new biomarker as prognostic predictors for future thyroid cancer patients after surgery, the investigators also plan to observe current patients with thyroid follicular cancer. Up to date, follicular thyroid cancer cannot be diagnosed preoperatively via images or aspiration cytology, because pathology after surgery is the only diagnostic golden rule. According to the observations conducted in the current experiment, the urine exosomal thyroglobulin has the opportunity to be a way to diagnose thyroid follicular carcinoma before surgery.
- Keywords
- Exosome, Urine, Biological marker, Thyroglobulin, Galactin-3
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary, Adenocarcinoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum thyroglobulin level
Thyroid function test
Measured: Within 36 months
Change of serum free T4 level
Thyroid function test
Measured: Within 36 months
Change of serum TSH level
Thyroid function test
Measured: Within 36 months
Change of anti-thyroglobulin level
Thyroid function test
Measured: Within 36 months
Urinary exosomal thyroglobulin detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal galectin-3 detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal calprotectin A9 detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal transketolase detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal keratin 19 detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal angiopoietin-1 detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal tissue inhibitor of metalloproteinase detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal keratin 8 detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal calprotectin A8 detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal annexin II detection
Urinary exosomal biomarker
Measured: Within 36 months
Urinary exosomal afamin detection
Urinary exosomal biomarker
Measured: Within 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start19 Aug 2021
- Primary completion8 Apr 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIH-YUAN WANG, Doctor, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948437
- Sponsor's protocol ID
- 202012036RIND
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2021
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of Well-differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04948437
- Acronym / sponsor ID
- 202012036RIND
- Keywords
- Exosome, Urine, Biological marker, Thyroglobulin, Galactin-3
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 8 Apr 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 2 Jul 2021 (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.
Now, the investigators carried out a prospective study enrolling patients with thyroid cancer, who had received ablative thyroidectomy and /or radioactive iodine therapy for two more years. The investigators' study already enrolled seventy-three patients with thyroid cancer, and the investigators plan to enroll 30 new patients in this consecutive research study. All patients received total thyroidectomy under clinically surgical judgement in initial therapeutic option. The investigators also further found some difference between papillary thyroid cancer and follicular thyroid cancer, and the investigators will continue annually to closely monitor the change of U-Ex Tg and urinary exosomal galectin-3 between differently cellular types of thyroid cancers.
Detailed description
Although, most thyroid cancers are clinically endocrine tumors of low malignancy, most patients usually receive radioactive iodine-131 treatment and thyroidectomy. Such patients are followed up with thyroid ultrasound and continuous serum thyroglobulin assessment after surgery. Previous studies have shown that one third of well-differentiated thyroid cancers may be transformed into poorly differentiated or even fatal malignant tumors during disease progression, but the efficacy of surgery, chemotherapy and external radiation therapy is not significant. . In other words, effective treatment strategies and tracking models will be very important, including surgical removal of thyroid cancer, radioactive iodine-131 treatment, and tracking of biomarkers in thyroid cancer.
When thyroid cancer cells are poorly differentiated, cell dedifferentiation is a key factor for malignant transformation and invasion. Usually in papillary thyroid carcinoma and follicular thyroid carcinoma, the cancer cells will gradually dedifferentiate, and undifferentiated thyroid carcinoma is the final result. Therefore, the investigators try to find biomarkers and therapeutic tracking targets based on the expression of exosomal proteins in urine. The basis of this clinical study depends on the previous basic experiments of culturing undifferentiated thyroid cancer cells.
Exosomes are nanosomes that are secreted into the extracellular environment. Cancer cell-derived exosomes can be found in the plasma, saliva, urine and other body fluids of cancer patients. The investigators will analyze exosomal proteins in urine, including thyroglobulin and galectin-3, and discover early prognostic biomarkers in urine through the prospectively observation study. The investigators have published preliminary research papers on 16 patients with thyroid mastoid carcinoma and follicular carcinoma in international scientific journals. During the period of surgery and further radioactive iodine-131 therapy, including before and one day after surgery, 3 months and 6 months after surgery, the urinary biomarkers of thyroglobulin and galectin-3 in the urine were analyzed at different stages . A prospective study currently in progress has enrolled 73 patients with thyroid mastoid carcinoma and follicular carcinoma. After thyroidectomy, urine was collected during outpatient follow-up and analyzed for exosome biomarkers in the urine. During the first two years of this project, such new urinary biomarkers of thyroid papillary carcinoma and thyroid follicular carcinoma had shown certain different patterns. The investigators' research team expects to enroll 30 new thyroid cancer patients in this consecutive plan. Under continuous follow-up research, in addition to identifying the clinical application of new biomarker as prognostic predictors for future thyroid cancer patients after surgery, the investigators also plan to observe current patients with thyroid follicular cancer. Up to date, follicular thyroid cancer cannot be diagnosed preoperatively via images or aspiration cytology, because pathology after surgery is the only diagnostic golden rule. According to the observations conducted in the current experiment, the urine exosomal thyroglobulin has the opportunity to be a way to diagnose thyroid follicular carcinoma before surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators carried out a prospective study enrolling patients with thyroid cancer, who had received ablative thyroidectomy and /or radioactive iodine therapy for two more years. The study already enrolled seventy-three patients with thyroid cancer, and the investigators plan to enroll 30 new patients in this consecutive research study. All patients received total thyroidectomy under clinically surgical judgement in initial therapeutic option. The investigators also further found some difference between papillary thyroid cancer and follicular thyroid cancer, and we will continue annually to closely monitor the change of U-Ex Tg and urinary exosomal galectin-3 between differently cellular types of thyroid cancers.
Key inclusion criteria (1 listed)
- diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer, post-operation follow up
Key exclusion criteria (1 listed)
- unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer
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
Change of serum thyroglobulin level
Time frame: Within 36 months
Thyroid function test
Change of serum free T4 level
Time frame: Within 36 months
Thyroid function test
Change of serum TSH level
Time frame: Within 36 months
Thyroid function test
Change of anti-thyroglobulin level
Time frame: Within 36 months
Thyroid function test
Urinary exosomal thyroglobulin detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal galectin-3 detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal calprotectin A9 detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal transketolase detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal keratin 19 detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal angiopoietin-1 detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal tissue inhibitor of metalloproteinase detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal keratin 8 detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal calprotectin A8 detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal annexin II detection
Time frame: Within 36 months
Urinary exosomal biomarker
Urinary exosomal afamin detection
Time frame: Within 36 months
Urinary exosomal biomarker
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 13 Apr 2026.
- 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.
CHIH-YUAN WANG, Doctor principal investigator
Department of Internal Medicine, National Taiwan University 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 and Papillary Thyroid Cancer, 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum thyroglobulin level (time frame: Within 36 months). The study lists 15 primary outcomes in all. 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 13 Apr 2026.