microRNA in Thyroid Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01964508
First received: October 14, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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 Intervention
FNA
microRNA
Thyroid Cancer
Thyroid Nodule
Other: Fine needle aspiration

Study Type: Observational [Patient Registry]
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • microRNA expression in thyroid cancer [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

FNA samples, CDNA, RNA


Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thyroid nodule
Patients with thyroid nodules undergoing FNA.
Other: Fine needle aspiration

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients undergoing FNA

Criteria

Inclusion Criteria:

  • Patients undergoing thyroid nodule biopsy; patients signing informed consent

Exclusion Criteria:

  • Patients that cannot sign an informed consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964508

Contacts
Contact: Haggi Mazeh, MD 00 972 2 5844550 hmazeh@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Haggi Mazeh, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01964508     History of Changes
Other Study ID Numbers: HM0003-HMO-CTIL
Study First Received: October 14, 2013
Last Updated: October 14, 2013
Health Authority: Israel: Ministry of Health - Director General

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

ClinicalTrials.gov processed this record on August 26, 2014