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NCT Number: NCT04948437

Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Thyroid Cancer Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Follicular Thyroid Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Papillary Thyroid Cancer Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chih-Yuan Wang, M.D

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer, post-operation follow up

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Change of serum thyroglobulin level

    Time frame: Within 36 months

    Thyroid function test

  2. Change of serum free T4 level

    Time frame: Within 36 months

    Thyroid function test

  3. Change of serum TSH level

    Time frame: Within 36 months

    Thyroid function test

  4. Change of anti-thyroglobulin level

    Time frame: Within 36 months

    Thyroid function test

  5. Urinary exosomal thyroglobulin detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  6. Urinary exosomal galectin-3 detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  7. Urinary exosomal calprotectin A9 detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  8. Urinary exosomal transketolase detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  9. Urinary exosomal keratin 19 detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  10. Urinary exosomal angiopoietin-1 detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  11. Urinary exosomal tissue inhibitor of metalloproteinase detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  12. Urinary exosomal keratin 8 detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  13. Urinary exosomal calprotectin A8 detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  14. Urinary exosomal annexin II detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

  15. Urinary exosomal afamin detection

    Time frame: Within 36 months

    Urinary exosomal biomarker

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of Well-differentiated Thyroid Cancer

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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