Clinical trial NCT04948437: Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of Thyroid Cancer
Official title: Urinary Exosomal Biomarkers of Thyroglobulin and Galectin-3 for Prognosis and Follow-up in Patients of Well-differentiated Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Papillary Thyroid Cancer
Follicular Thyroid Cancer
Keywords: Exosome
Urine
Biological marker
Thyroglobulin
Galactin-3
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of serum thyroglobulin level
timeFrame: Within 36 months
measure: Change of serum free T4 level
timeFrame: Within 36 months
measure: Change of serum TSH level
timeFrame: Within 36 months
measure: Change of anti-thyroglobulin level
timeFrame: Within 36 months
measure: Urinary exosomal thyroglobulin detection
timeFrame: Within 36 months
measure: Urinary exosomal galectin-3 detection
timeFrame: Within 36 months
measure: Urinary exosomal calprotectin A9 detection
timeFrame: Within 36 months
measure: Urinary exosomal transketolase detection
timeFrame: Within 36 months
measure: Urinary exosomal keratin 19 detection
timeFrame: Within 36 months
measure: Urinary exosomal angiopoietin-1 detection
timeFrame: Within 36 months
measure: Urinary exosomal tissue inhibitor of metalloproteinase detection
timeFrame: Within 36 months
measure: Urinary exosomal keratin 8 detection
timeFrame: Within 36 months
measure: Urinary exosomal calprotectin A8 detection
timeFrame: Within 36 months
measure: Urinary exosomal annexin II detection
timeFrame: Within 36 months
measure: Urinary exosomal afamin detection
timeFrame: Within 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chih-Yuan Wang, M.D
Study officials:
affiliation: Department of Internal Medicine, National Taiwan University Hospital
name: CHIH-YUAN WANG, Doctor
role: PRINCIPAL_INVESTIGATOR
References: