Circulating Biomarkers to Identify Thyroid Cancer

NCT04594720 | Completed

• 1 other identifier: 201801437B0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Cancer; Thyroid Cancer, Papillary; Benign Thyroid Tumor

Outcome Measures

Primary Outcomes (1)

• Stage of thyroid cancers

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

  1 months after surgery

Study Arms (1)

Thyroid cancers

Enrolled study population have papillary thyroid cancers and benign thyroid tumors

Other: Identification group; Other: Validation group

Interventions

Identification group OTHER

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

Thyroid cancers

Validation group OTHER

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

Thyroid cancers

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was assigned to 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). Before surgery, 2 mL blood samples were drawn from an elbow vein of patients into EDTA tubes (BD Vacutainer) for RNA analysis, and 8 mL into SST™II advance tubes (BD Vacutainer) for protein analysis.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 20, 2020
• Study Start: October 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: September 30, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

TW (1)