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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948437
• Other study ID #: 202012036RIND
• Status: Recruiting
• Start date: August 19, 2021
• Est. completion date: October 31, 2026

Study information

• Verified date: October 2022
• Source: National Taiwan University Hospital
• Contact: CHIH-YUAN WANG, Doctor
• Phone: +886-2-23123456
• Email: cyw1965[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Follicular Thyroid Cancer
• Papillary Thyroid Cancer
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Taiwan	Chih-Yuan Wang, M.D	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum thyroglobulin level	Thyroid function test	Within 36 months
Primary	Change of serum free T4 level	Thyroid function test	Within 36 months
Primary	Change of serum TSH level	Thyroid function test	Within 36 months
Primary	Change of anti-thyroglobulin level	Thyroid function test	Within 36 months
Primary	Urinary exosomal thyroglobulin detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal galectin-3 detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal calprotectin A9 detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal transketolase detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal keratin 19 detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal angiopoietin-1 detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal tissue inhibitor of metalloproteinase detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal keratin 8 detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal calprotectin A8 detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal annexin II detection	Urinary exosomal biomarker	Within 36 months
Primary	Urinary exosomal afamin detection	Urinary exosomal biomarker	Within 36 months