- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01964508
microRNA in Thyroid Cancer
March 15, 2022 updated by: Hadassah Medical Organization
The Use of a microRNA Panel to Identify Thyroid Malignancy in FNA Leftover Cells and the Effect of These microRNAs on Target Genes.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jerusalem, Israel
- Hadassah Medical Organization
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing FNA
Description
Inclusion Criteria:
- Patients undergoing thyroid nodule biopsy; patients signing informed consent
Exclusion Criteria:
- Patients that cannot sign an informed consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Thyroid nodule
Patients with thyroid nodules undergoing FNA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
microRNA expression in thyroid cancer
Time Frame: 24 months
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24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2013
Primary Completion (Actual)
December 30, 2015
Study Completion (Actual)
December 30, 2015
Study Registration Dates
First Submitted
October 14, 2013
First Submitted That Met QC Criteria
October 14, 2013
First Posted (Estimate)
October 17, 2013
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM0003-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
Clinical Trials on Fine needle aspiration
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Assistance Publique - Hôpitaux de ParisWithdrawn
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Carol Fabian, MDIntergenetics, Inc.WithdrawnBreast CancerUnited States
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Washington University School of MedicineWithdrawnUveal Neoplasms | Choroid Neoplasms | Iris NeoplasmsUnited States
-
Rigshospitalet, DenmarkUnknown
-
M.D. Anderson Cancer CenterCompletedLymphadenopathyUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Kashani Social Security HospitalUnknownPalpable Breast MassIran, Islamic Republic of
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingThermal Ablation | Thyroid Nodules | Fine Needle Aspiration Biopsy
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Kocaeli UniversityRecruiting
-
Northwestern UniversityCompletedPancreatic Cancer | Lymphadenopathy | Gastrointestinal Stromal TumorUnited States