Predicting Prognosis and Recurrence of Thyroid Cancer Via New Biomarkers, Urinary Exosomal Thyroglobulin and Galectin-3

NCT03488134 | Completed

• 1 other identifier: 201711082RINA
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Although thyroid cancers are low-grade endocrine malignancy, most patients usually received thyroidectomy with ablative radioactive iodine therapy. Such patients were followed with thyroid ultrasonography and serial serum thyroglobulin evaluation. Prior researches indicated that one-third well-differentiated thyroid cancers could transform to poorly-differentiated patterns, even to be anaplastic thyroid cancer (ATC), a fatal malignancy, and no effective therapeutic strategies was noted, including surgical intervention, chemotherapy and radiotherapy. The poorly-differentiated or anaplastic change of thyroid cancer cells proliferates rapidly and always invades local tissues with distant metastasis. Cellular de-differentiation is the most pivotal cause for malignant transformation and invasion. De-differentiation usually in papillary thyroid cancer and follicular thyroid cancer, and definitely in ATC. Therefore, the investigators try to find the biological markers and therapeutic targets via the exosomal expression in urine. On the continuing basis of prior ATC cells culture experiments. Exosomes are nanovesicles secreted into extracellular environments. Cancer cell-derived exosomes could be found in plasma, saliva, urine and other body fluid of patients with cancer. The investigators try to analyze the urinary exosomal proteins, including thyroglobulin and galectin-3, to find the early prognostic biological markers in urine via this prospective study. The investigators expected to enroll 150 post-operative patients with papillary, follicular or anaplastic thyroid cancer, and collect the urine samples in outpatient clinic per year. The investigators will analyze the urine exosomal proteins and probable biological markers, including thyroglobulin and galectin-3. The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic and follow-up pathway for such patients with well-differentiated or anaplastic thyroid cancer.

Conditions

Thyroid Cancer

Keywords

Exosome; Anaplastic thyroid cancer; Urine; Biological marker; Thyroglobuin; Galectin-3

Outcome Measures

Primary Outcomes (1)

• Prognostic biological markers via this prospective study

  The study was designed as prospective pattern, and the investigators enrolled thyroid cancer with follow-up, then urine exosome protein will be measured and reported. The investigators try to find the correlation of outcome ( including recurrence, lymph nodes metastasis..) together with unknown/fresh biomarkers in this study and time-dependent manner. Such biomarkers including thyroglobulin, galectin-3, Calprotectin A8, Calprotectin A9, TKT, Annexin II, Afamin, Keratin 8, Keratin 9, Angiopoietin-1 and TIMP will be measured.

  3 years

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will enroll 150 post-operative patients with papillary, follicular or anaplastic thyroid cancer, and collect their urine samples in outpatient clinic per year. The investigators will analyze the urine exosomal proteins and probable biological markers, including thyroglobulin and galectin-3. The investigators hope to find the prognostic biological markers via this prospective study. The investigators further hope to find newly therapeutic and follow-up pathway for such patients with well-differentiated or anaplastic thyroid cancer.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei City, 100-02, Taiwan

Location

Related Publications (2)

• Wang CY, Shih SR, Chen KY, Chung YC, Huang PJ. Long-Term Changes of Urinary Exosomal Peptide Levels After Thyroidectomy in Patients with Thyroid Cancer: A Prospective Observational Study. Int J Nanomedicine. 2024 May 23;19:4667-4677. doi: 10.2147/IJN.S458931. eCollection 2024.

  PMID: 38803995 DERIVED

• Huang TY, Wang CY, Chen KY, Huang LT. Urinary Exosomal Thyroglobulin in Thyroid Cancer Patients With Post-ablative Therapy: A New Biomarker in Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Jun 16;11:382. doi: 10.3389/fendo.2020.00382. eCollection 2020.

  PMID: 32612576 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Carcinoma, Anaplastic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• CHIH-YUAN WANG, Doctor

  Department of Internal Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 4, 2018
• Study Start: August 3, 2018
• Primary Completion: July 31, 2023
• Study Completion: February 20, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)