Circulating Biomarkers to Identify Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Using Circulating Biomarkers to Identify Thyroid Cancer From the Patients With Thyroid Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594720
• Other study ID #: 201801437B0
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to identify the potential circulating biomarkers of protein, mRNAs, and long non-coding RNAs (lncRNAs) to differentiate the papillary thyroid cancers from benign thyroid tumors. Methods: The study population of 100 patients was classified into identification (10 patients with papillary thyroid cancers and 10 patients with benign thyroid tumors) and validation groups (45 patients with papillary thyroid cancers and 35 patients with benign thyroid tumors). The Sengenics Immunome Protein Array combined data mining approach using the Open Targets Platform was used to identify the putative protein biomarkers, and their expression validated using the enzyme-linked immunosorbent assay. Next-generation sequencing by Illumina HiSeq was used for the detection of dysregulated mRNAs and lncRNAs. The website Timer v2.0 helped identify the putative mRNA biomarkers, which were significantly over-expressed in papillary thyroid cancers than in adjacent normal thyroid tissue. The mRNA and lncRNAs biomarker expression was validated by a real-time polymerase chain reaction.

Description:

Novel biomarkers identification from liquid biopsy samples is in great demand for the diagnosis for malignant diseases. Generally, blood sampling is less invasive and could be carried out repeatedly. In addition to protein markers, circulating nucleic acids are promising sources of cancer biomarkers , since circulating nucleic acids provide information on the genome or gene expression , and harbor wealth of health and disease status information. The long non-coding RNAs (lncRNAs) are the transcripts longer than 200 nucleotides in length and act as prominent regulators of gene expression. Accumulating evidence demonstrated the involvement of lncRNA dysregulation in a variety of cancers, and their expression is associated with cancer development and metastasis. This study was designed to identify the potential protein and RNA biomarkers in the blood for differentiating a malignant thyroid tumor from a benign thyroid nodule. In this study, only patients with papillary thyroid carcinoma, the most common type of thyroid cancer, were chosen for comparison with those with benign thyroid tumors to simplify the comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with thyroid nodules who received total or subtotal thyroidectomy
• Patients aged 20 years and above

Exclusion Criteria:

• Patients with any other type of cancer, immunocompromised disease, or autoimmune disease.

Related Conditions & MeSH terms

• Benign Thyroid Tumor
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Identification group
papillary thyroid cancers (n=10) and benign thyroid tumors (n=10)
• Validation group
papillary thyroid cancers (n=45) and benign thyroid tumors (n=35)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage of thyroid cancers	The final diagnosis of malignant or benign lesions was based on the pathological reports.	1 months after surgery