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Thyroid CancerNCT05463107

Correlation Between Various Urinary Exosomal Protein Biomarkers and Pathological Manifestation in Thyroid Follicular Neoplasm: Early and Pre-operative Diagnosis of Follicular Thyroid Cancer

An observational study of Thyroid Cancer and Follicular Thyroid Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Thyroid cancer is the most common endocrine malignancy in the world. Generally, thyroid cancer could be divided into well-differentiated and poorly-differentiated. Well-differentiated thyroid cancers usually have two different patterns, including papillary thyroid cancer and follicular thyroid cancer. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Thyroid Cancer, Follicular Thyroid Cancer
How many people
50 participants
Where
1 siteTaiwan
Study dates
1 Aug 2022to 31 Jul 2028
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: Clinical study was designed as prospective pattern, and enrolled patients with nodular goiter or multinodular goiter, who had received fine needle aspiration cytology and/or thyroidectomy. Cytology and complete surgical pathology survey will be recorded for cytological and surgical samples. This study will enroll 50 consecutive patients with nodular goiter or multinodular goiter in 2nd and 3rd years.

Who may be able to join

  • diagnosed patients with nodular goiter or multinodular goiter, thyroid papillary, follicular and anaplastic thyroid cancer, pre-operation.

Who cannot join

  • unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Thyroid cancer is the most common endocrine malignancy in the world. Generally, thyroid cancer could be divided into well-differentiated and poorly-differentiated. Well-differentiated thyroid cancers usually have two different patterns, including papillary thyroid cancer and follicular thyroid cancer. Thyroid sonography is convenient to obtain repeatedly for the images of nodular goiter. However, cytology and pathology are still the golden rules to make the final diagnosis. Under the basis of sono-guided fine needle aspiration cytology, diagnosis of papillary thyroid cancer is typically using fine needle aspiration cytology based on the presentation of typical cytologic features. On the other hand, thyroid follicular lesion cannot be interpretated via cytology because the evidence of capsular invasion or vascular permeation of capsule will not be available in fine needle aspiration cytology. Surgical intervention with pathological specimens is the only pathway to make the final diagnosis. Interestingly, both patterns of well-differentiated thyroid cancer shared the same follow-up tumor marker, i.e. serum thyroglobulin. Up to date, pre-operative diagnosis of follicular thyroid cancer is still one of the unresolved issues in endocrine oncology.

Read the detailed description

Thyroid cancer is one of the most popular malignancy in the past several decades all over the world. For poorly-differentiated thyroid cancer, therapeutic strategy of costly target therapy together with immune therapy will be the pivotal one because of its poor prognosis. The average 5-year relative survival rate of anaplastic thyroid cancer is only 3 to 31 % on the stage from distant metastasis to localized disease.

However, it will be very different for well-differentiated thyroid cancer, and the average 5-year relative survival rate of both thyroid papillary or follicular thyroid cancer is more than 98 %. Therefore, the most important treatment strategy for endocrinologists will consider the development of biomarkers for early diagnosis and postoperative follow-up, rather than measuring serum thyroglobulin alone, which is the only biomarker in the current medical guidelines, and there is no choice. Our research team tried to find the newer biomarker together with serum thyroglobulin for post-operative longitudinal follow-up of well-differentiated thyroid cancer in the past five years. The investigators used urinary exosomal proteins as target and did find several peptides to be helpful, including our published urinary exosomal thyroglobulin (UExTg). In Taiwan, goiter and thyroid cancer are prevalent diseases. Although papillary thyroid cancer could be diagnosed via reliable sono-guided fine needle aspiration cytology, follicular thyroid cancer is still an unresolved issue in daily medical practice, especially in cytology. the investigators need to find a practicably earlier biomarker, which should be convenient, non-invasive and repeatable in sample collection. In our previous research and published data, urine will be a reliable source of data.

Exosomes are nano-vesicles, containing DNA, RNA and proteins, and usually secreted by cells into extracellular spaces. Generally, the vesicles of exosomes are only 40 to 150 nm in diameter. Exosomes may carry and transfer the messages between different tissues. Now, the existing evidences revealed that exosomes may represent certain messages from malignant cells, including diagnosed biomarkers or prognostic predictors. Previously, published data of exosomal studies in thyroid cancer focused on serum microRNA, long coding RNA and circular RNA, but only few published data on peptides, which were named as liquid biopsy. However, cell-secreted exosomes of malignancy could be collected not only in plasma, body fluid, but also from urine, which is the non-invasive pathway but valuable wastes of human body. Our research group had developed experienced technique to collect urinary exosomes via our pilot study in the past several years.

Since the investigators proved the role of urinary exosomal thyroglobulin, UExTg, in post-operative follow-up in well-differentiated thyroid cancer in the past three years, from 2018-2020, the investigators also found several peptides to be the candidates of prognostic predictors in our preliminary studies, including Calprotectin A8/A9, Annexin-2, Angiopoietin-1.

Keywords
Exosome, Urine, Biological marker, Thyroglobulin, Galactin-3
Medical subject headings
Thyroid Neoplasms, Adenocarcinoma, Follicular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of serum thyroglobulin level

    Thyroid function test

    Measured: Within 36 months

  2. Change of serum free T4 level

    Thyroid function test

    Measured: Within 36 months

  3. Change of serum TSH level

    Thyroid function test

    Measured: Within 36 months

  4. Change of anti-thyroglobulin level

    Thyroid function test

    Measured: Within 36 months

  5. Urinary exosomal thyroglobulin detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  6. Urinary exosomal galectin-3 detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  7. Urinary exosomal calprotectin A9 detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  8. Urinary exosomal transketolase detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  9. Urinary exosomal keratin 19 detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  10. Urinary exosomal angiopoietin-1 detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  11. Urinary exosomal tissue inhibitor of metalloproteinase detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  12. Urinary exosomal keratin 8 detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  13. Urinary exosomal calprotectin A8 detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  14. Urinary exosomal annexin II detection

    Urinary exosomal biomarker

    Measured: Within 36 months

  15. Urinary exosomal afamin detection

    Urinary exosomal biomarker

    Measured: Within 36 months

Secondary outcomes (2)

  1. Thyroid fine needle aspiration cytology

    Urinary exosomal biomarker

    Measured: Within 36 months

  2. Ultrasonography of thyroid nodules

    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.

  1. First posted18 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion8 Apr 2026 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463107
Sponsor's protocol ID
202110076RINB
Status last verified
Jun 2025
First submitted
14 Jul 2022
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer and Follicular 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?

On the ClinicalTrials.gov record for NCT05463107.

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.

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