microRNA in Thyroid Cancer

NCT01964508 | Completed

• 1 other identifier: HM0003-HMO-CTIL
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Thyroid cancer is the most common endocrine malignancy and its incidence is rapidly increasing. Palpable thyroid nodules are very common, affecting up to 5% of the general population. Nevertheless, only 5% of the thyroid nodules harbor malignancy, hence the obvious need to accurately characterise these nodules. Ultrasound guided fine needle aspiration biopsy (FNAB) is the most important tool in assessing the nature of thyroid nodules, however, in up to 30% of the biopsies the results are indeterminate. In this proposal, the investigators hypothesize that leftover cells in the FNAB needle may be utilized for molecular analysis with an established microRNA panel and distinguish between malignant and benign lesions. Despite established studies on the diagnostic utility of microRNAs in thyroid nodules, the effect of microRNAs on specific target genes involved in thyroid cancer is poorly studied. In this proposal the investigators hypothesize that the microRNAs identified in our panel will affect intracellular pathways by regulating target genes that are involved in thyroid tumorigenesis. The investigators present preliminary data that confirms that microRNA panel may identify malignancy in thyroid nodules. In aim 1 the investigators will identify the expression profile of miRNAs in the different thyroid cancers. the investigators will statistically quantify the threshold of miRNA dysregulation for malignancy on a large number of tumor and benign samples. This will serve as matrix for defining malignancy on the FNAB samples. In aim 2 the investigators will establish a reliable reproducible method to extract RNA from cells left over in FNAB samples. the investigators' preliminary data support the feasibility of the method and it has not been described previously. This will be the first study that will compare cytology results and microRNA panel analysis on the very same FNAB cells. It will mimic the exact clinical scenario that such microRNA panel can be utilized in the future. Finally, in aim 3 the investigators will characterize the effect of microRNAs on target genes expression. the investigators will identify possible target genes from bioinformatics databases and will perform quantitative measurement of mRNA level of target gene by real time PCR and immunohistochemistry. These studies will hopefully support the utility of microRNAs as a diagnostic tool to accurately identify malignancy in thyroid FNAB leftover cells and point out possible target genes for future therapeutic approaches. This could impact many patients, as thyroid cancer is the 5th most common cancer in women, and the most rapidly growing malignancy in both men and women.

Conditions

FNA; microRNA; Thyroid Cancer; Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• microRNA expression in thyroid cancer

  24 months

Study Arms (1)

Thyroid nodule

Patients with thyroid nodules undergoing FNA.

Other: Fine needle aspiration

Interventions

Fine needle aspiration OTHER

Thyroid nodule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing FNA

You may qualify if:

• Patients undergoing thyroid nodule biopsy; patients signing informed consent

You may not qualify if:

• Patients that cannot sign an informed consent form.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

FNA samples, CDNA, RNA

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 17, 2013
• Study Start: September 12, 2013
• Primary Completion: December 30, 2015
• Study Completion: December 30, 2015
• Last Updated: March 31, 2022

Record last verified: 2013-10

Locations

IL (1)