Circulating Biomarkers to Identify Thyroid Cancer

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.

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Key information

Conditions

Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Benign Thyroid Tumor Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Identification group

Other

papillary thyroid cancers (n=10) and benign thyroid tumors (n=10)

Validation group

Other

papillary thyroid cancers (n=45) and benign thyroid tumors (n=35)

Primary outcomes

Stage of thyroid cancers

Time frame: 1 months after surgery

The final diagnosis of malignant or benign lesions was based on the pathological reports.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Oct 20, 2020
Registry last updated: Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed