Clinical Trials Directory

Trials / Completed

CompletedNCT04594720

Circulating Biomarkers to Identify Thyroid Cancer

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
20 Years – 100 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERIdentification grouppapillary thyroid cancers (n=10) and benign thyroid tumors (n=10)
OTHERValidation grouppapillary thyroid cancers (n=45) and benign thyroid tumors (n=35)

Timeline

Start date
2018-10-01
Primary completion
2019-10-31
Completion
2020-09-30
First posted
2020-10-20
Last updated
2020-10-20

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04594720. Inclusion in this directory is not an endorsement.