Circulating Biomarkers to Identify Thyroid Cancer

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04594720
Study type	Observational
Source	Chang Gung Memorial Hospital
Contact
Status	Completed
Phase
Start date	October 1, 2018
Completion date	September 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05774535` - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn	`NCT04224792` - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors	N/A
Completed	`NCT01728623` - A Study of E7080 in Subjects With Advanced Thyroid Cancer	Phase 2
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT02911155` - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting	`NCT05025046` - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting	`NCT03978351` - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed	`NCT02658513` - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1
Completed	`NCT02375451` - Effect of Childhood Radioiodine Therapy on Salivary Function	N/A
Withdrawn	`NCT01994200` - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients	Phase 1/Phase 2
Terminated	`NCT01403324` - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer	N/A
Completed	`NCT00970359` - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244	N/A
Completed	`NCT00439478` - Dental Safety Profile of High-Dose Radioiodine Therapy	Phase 4
Completed	`NCT00223158` - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer	N/A
Active, not recruiting	`NCT04544111` - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	Phase 2
Completed	`NCT04876287` - Salivary dysfuncTion After Radioiodine Treatment
Recruiting	`NCT06073223` - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer	N/A
Recruiting	`NCT06037174` - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Recruiting	`NCT04952493` - Anlotinib or Penpulimab in Combination With RAI for DTC	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.