microRNA in Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01964508
Recruitment Status : Unknown
Verified October 2013 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Information provided by (Responsible Party):
Hadassah Medical Organization

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 characterize 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, we 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 we hypothesize that the microRNAs identified in our panel will affect intracellular pathways by regulating target genes that are involved in thyroid tumorigenesis. We present preliminary data that confirms that microRNA panel may identify malignancy in thyroid nodules. In aim 1 we will identify the expression profile of miRNAs in the different thyroid cancers. We 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 we will establish a reliable reproducible method to extract RNA from cells left over in FNAB samples. Our 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 we will characterize the effect of microRNAs on target genes expression. We 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.

Condition or disease Intervention/treatment
FNA microRNA Thyroid Cancer Thyroid Nodule Other: Fine needle aspiration

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Use of a microRNA Panel to Identify Thyroid Malignancy in FNA Leftover Cells and the Effect of These microRNAs on Target Genes.
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Thyroid nodule
Patients with thyroid nodules undergoing FNA.
Other: Fine needle aspiration

Primary Outcome Measures :
  1. microRNA expression in thyroid cancer [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
FNA samples, CDNA, RNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing FNA

Inclusion Criteria:

  • Patients undergoing thyroid nodule biopsy; patients signing informed consent

Exclusion Criteria:

  • Patients that cannot sign an informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01964508

Contact: Haggi Mazeh, MD 00 972 2 5844550
Contact: Hadas Lemberg, PhD 00 972 2 6777572

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Haggi Mazeh, MD         
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization Identifier: NCT01964508     History of Changes
Other Study ID Numbers: HM0003-HMO-CTIL
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Nodule
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms