Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03061318
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2017-02-17
Brief Title:
Validation of a Multi-Genetic Test for the Diagnosis of Indeterminate Thyroid Nodules
Sponsor:
Hernán González
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Validation of a Multi-Genetic Test for the Diagnosis of Indeterminate Thyroid Nodules
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CT-DS
Brief Summary:
A clinical trial is proposed to clinically validate the diagnostic performance of a new genetic test developed in Chile It will determine the nature of thyroid nodules that have been informed as indeterminate by cytology through a fine needle aspiration FNA
The Genetic Classifier for Indeterminate Thyroid Nodules is a quantitative gene expression test that combines the results for a panel of 10 biomarkers CXCR3 CCR3 CXCl10 CK19 TIMP1 CLDN1 CAR XB130 HO-1 and CCR7 to generate a single number score It is indicated on patients with a thyroid nodule informed by cytology as indeterminate Bethesda III and IV according to The Bethesda System for Reporting Thyroid Cytopathology This test would be used by taking a sample with a fine needle aspiration FNA and thus being able to predict with high accuracy benign nodules that do not require surgery
The Genetic Classifier for Indeterminate Thyroid Nodules is a quantitative gene expression test that combines the results for a panel of 10 biomarkers CXCR3 CCR3 CXCl10 CK19 TIMP1 CLDN1 CAR XB130 HO-1 and CCR7 to generate a single number score It is indicated on patients with a thyroid nodule informed by cytology as indeterminate Bethesda III and IV according to The Bethesda System for Reporting Thyroid Cytopathology This test would be used by taking a sample with a fine needle aspiration FNA and thus being able to predict with high accuracy benign nodules that do not require surgery
Detailed Description:
ProblemNecessity Throughout the world each year hundreds of thousands of patients undergo an unnecessary diagnostic surgery of the thyroid This occurs in patients that have a FNA informed as indeterminate which correspond to 15-20 of all FNA due to have a risk of malignancy ranging from 15 to 25 So 75 of the indeterminate nodules are unnecessarily operated which makes it essential to have a diagnostic tool that allows us to identify those patients with benign thyroid nodules and thus avoid surgery
Solution We have developed a test that through the analysis of the expression of 10 genes by PCR on real time in FNA samples integrated by an algorithm rules out the presence of cancer with a Negative Predictive Value NPV of 96 and Specificity of 81
BenefitJustification The high NPV will allow the clinician to recommend observation as an alternative to surgery The 6 of false negatives is clinically accepted due to cytology on its own has 5 of false negatives On the other hand the 75 of specificity will allow to avoid surgery on 75 of the benign cases which makes the test cost-effective
State of Progress The test has completed the phase of prototype development and analytical validation The next stage is the clinical validation and it corresponds to the study proposed on this protocol
Hypothesis Our genetic test rules out the presence of cancer with a NPV higher that 94 and Specificity higher than 75 on indeterminate nodule samples
Proposed study A multi-centric 9 sites clinical trial will be developed in Chile with statistical power to determine the sensitivity and clinical specificity negative and positive predictive values likelihood ratios and confidence intervals
Method Patients that have a FNA indicated by their treating physician due to they have an indeterminate nodule that requires to be determined if it is benign or malignant will be invited to participate on this trial After the informed consent is signed a FNA sample will be obtained for cytology and for molecular study Obtaining the sample for the molecular study will be part of the same procedure A maximum of 4000 samples must be enrolled Approximately 300 will fulfill all of the requirements to complete the study which include having a confirmed indeterminate cytology be sent to surgery gold standard and have a proper mRNA sample Throughout the study the treating physician will not modify his conduct at any time and the decisions will be based on the clinical information that is regularly used
TimelineMonitoring The study recruitment phase is expected to last an approximate of 28 months 24 months of enrollment and 4 months of follow up as a minimum time to obtain the result for the surgical biopsy However this timeline might be extended while waiting for the 300 indeterminate samples to end study There will be a principal investigator on each site guided by a hired CRO will guard the correct execution of the trial
Solution We have developed a test that through the analysis of the expression of 10 genes by PCR on real time in FNA samples integrated by an algorithm rules out the presence of cancer with a Negative Predictive Value NPV of 96 and Specificity of 81
BenefitJustification The high NPV will allow the clinician to recommend observation as an alternative to surgery The 6 of false negatives is clinically accepted due to cytology on its own has 5 of false negatives On the other hand the 75 of specificity will allow to avoid surgery on 75 of the benign cases which makes the test cost-effective
State of Progress The test has completed the phase of prototype development and analytical validation The next stage is the clinical validation and it corresponds to the study proposed on this protocol
Hypothesis Our genetic test rules out the presence of cancer with a NPV higher that 94 and Specificity higher than 75 on indeterminate nodule samples
Proposed study A multi-centric 9 sites clinical trial will be developed in Chile with statistical power to determine the sensitivity and clinical specificity negative and positive predictive values likelihood ratios and confidence intervals
Method Patients that have a FNA indicated by their treating physician due to they have an indeterminate nodule that requires to be determined if it is benign or malignant will be invited to participate on this trial After the informed consent is signed a FNA sample will be obtained for cytology and for molecular study Obtaining the sample for the molecular study will be part of the same procedure A maximum of 4000 samples must be enrolled Approximately 300 will fulfill all of the requirements to complete the study which include having a confirmed indeterminate cytology be sent to surgery gold standard and have a proper mRNA sample Throughout the study the treating physician will not modify his conduct at any time and the decisions will be based on the clinical information that is regularly used
TimelineMonitoring The study recruitment phase is expected to last an approximate of 28 months 24 months of enrollment and 4 months of follow up as a minimum time to obtain the result for the surgical biopsy However this timeline might be extended while waiting for the 300 indeterminate samples to end study There will be a principal investigator on each site guided by a hired CRO will guard the correct execution of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None