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

NCT05463107 | Active Not Recruiting

• 1 other identifier: 202110076RINB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thyroid Cancer; Follicular Thyroid Cancer

Keywords

Exosome; Urine; Biological marker; Thyroglobulin; Galactin-3

Outcome Measures

Primary Outcomes (15)

• Change of serum thyroglobulin level

  Thyroid function test

  Within 36 months

• Change of serum free T4 level

  Thyroid function test

  Within 36 months

• Change of serum TSH level

  Thyroid function test

  Within 36 months

• Change of anti-thyroglobulin level

  Thyroid function test

  Within 36 months

• Urinary exosomal thyroglobulin detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal galectin-3 detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal calprotectin A9 detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal transketolase detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal keratin 19 detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal angiopoietin-1 detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal tissue inhibitor of metalloproteinase detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal keratin 8 detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal calprotectin A8 detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal annexin II detection

  Urinary exosomal biomarker

  Within 36 months

• Urinary exosomal afamin detection

  Urinary exosomal biomarker

  Within 36 months

Secondary Outcomes (2)

• Thyroid fine needle aspiration cytology

  Within 36 months

• Ultrasonography of thyroid nodules

  Within 36 months

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

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.

You may qualify if:

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

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, Taiwan

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Adenocarcinoma, Follicular

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma; 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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: August 1, 2022
• Primary Completion: April 8, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2025-06

Locations

TW (1)