Clinical Trial Multi-analyte Blood Test (CLiMB)
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. |
ClinicalTrials.gov Identifier: NCT03694600 |
Recruitment Status :
Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : September 29, 2023
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date | September 28, 2018 | ||||||||
First Posted Date | October 3, 2018 | ||||||||
Last Update Posted Date | September 29, 2023 | ||||||||
Actual Study Start Date | February 4, 2019 | ||||||||
Actual Primary Completion Date | February 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs Ultrasound [ Time Frame: 1 month ] The primary objective is to compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the multi-analyte blood Test for the detection of liver cancers within a high-risk population.
|
||||||||
Original Primary Outcome Measures |
Independent performance measure of sensitivity and specificity of IvyGene vs Ultrasound [ Time Frame: 1 month ] The primary objective is to compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the IvyGeneTM Dx Liver Cancer Test for the detection of liver cancers within a high-risk population.
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
|
||||||||
Original Secondary Outcome Measures |
|
||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Clinical Trial Multi-analyte Blood Test | ||||||||
Official Title | Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study | ||||||||
Brief Summary | This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone, ultrasound alone and the combination of both the multi-analyte blood test and ultrasound for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis. | ||||||||
Detailed Description | This multi-site, prospective study is designed to compare the sensitivity and specificity of a multi-analyte blood test alone, ultrasound alone and the combination of the multi-analyte blood test and ultrasound for the detection of HCC within a population at high risk of HCC due to liver cirrhosis. Subjects will be enrolled until the pre-determined number of subjects are enrolled. Subjects at high risk for developing HCC due to liver cirrhosis and who are eligible for liver cancer surveillance as determined by the patient's physician and who meet all inclusion and exclusion eligibility criteria as described in this protocol, will be invited to participate in this study. Subjects will then read, understand and sign the Informed Consent Form and the HIPAA Authorization Agreement for Medical Records Form. For each subject upon enrollment, the following blood analytes will also be determined: creatinine, prothrombin time, bilirubin, blood platelet count, ALT, AST and ALP. The results of all clinical laboratory tests will be recorded by use of the subject's Case Report Form. Whole blood samples drawn for the multi-analyte blood test will be collected (according to the instructions provided with each sample collection kit) by using the multi-analyte Sample Collection, Stabilization and Shipping Kit, and shipped to a central LAM laboratory for testing. Samples will be assayed by laboratory technicians blinded to the results of any other testing. Within the same clinical visit as the blood draws (when possible), subjects will undergo conventional ultrasound to examine the liver. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by LI-RADS score and the number and size of any malignant lesions identified will be recorded. The images of all MRI, CT, or ultrasound will be saved and uploaded for evaluation by a blinded, centralized team of radiologists to confirm diagnosis. Any biopsy results or surgical pathology results that are generated for study subjects as part of current clinical practice will also be recorded. Study procedures will consist of conventional ultrasound to examine the liver, providing blood samples for testing with the multi-analyte blood test and other conventional blood analytes, and diagnostic imaging by multiphasic MRI. Upon enrolling in the study, subjects will commence the Initial Surveillance Visit (t=0 months). During the Initial Surveillance Visit, all enrolled subjects will undergo ultrasound to examine the liver and provide blood samples for the multi-analyte blood test and for determining conventional blood analytes. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by a Liver Reporting and Data System (LI-RADS) score. The data of all diagnostic imaging by MRI will be saved and uploaded for evaluation by a blinded, centralized team of radiologists, which will be used as the basis of the clinical truth for all subjects. After the Initial Surveillance Visit (t=0 months), subjects with an indeterminant HCC finding by MRI (LI-RADS 3) will be recommended to up to three Follow-Up Visits (t=6 months, t=12 months, and t=18 months) to attempt to resolve the clinical truth for these subjects. Each Follow-Up Visit will consist of an ultrasound to examine the liver, providing blood samples for the multi-analyte blood test , as well as diagnostic imaging by multiphasic MRI. Although not required by this clinical protocol, any biopsy or surgical pathology results, or any additional imaging (such as multiphasic CT) that are generated for study subjects as part of current clinical practice will also be recorded for each subject and the results shall be made available to the Sponsor if performed within 6 months of a scheduled Visit. Biopsy and surgical pathology results that indicate a malignancy will be used in place of diagnostic imaging as the clinical truth for each subject if performed within 6 months of a scheduled visit and prior to database lock. All study-related procedures will occur during the Study Duration Period, which consists of the Initial Surveillance Visit for all subjects and up to three Follow-Up Visits for subjects with an initial indeterminant HCC finding (LI-RADS 3) by diagnostic imaging. After this Study Duration Period, no study related blood draws, imaging or procedures will occur for these subjects. |
||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Other Time Perspective: Prospective |
||||||||
Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | The maximum study duration for any given subject participating in the trial will be approximately 21 months (includes Initial Surveillance Visit and Follow-Up Visits at 6 months, 12 months and 18 months). No study-related lab assessments, imaging or procedures shall be required for any subject after the Study Duration Period. Subject Eligibility Screening Period: 14 days Study Duration Period: Up to 21 months (includes Initial Surveillance Visit for all subjects and up to three Follow-Up Visits ONLY for subjects with indeterminant findings by diagnostic imaging) The maximum observational window for any subject enrolled in the study is expected to be approximately 21 months (for subjects with indeterminant findings by diagnostic imaging). |
||||||||
Condition | Liver Cirrhosis | ||||||||
Intervention | Diagnostic Test: Multi-analyte blood Test
intended for the qualitative detection of DNA methylation profiles associated with hepatocellular carcinoma in cell-free DNA derived from patient whole blood specimens.
|
||||||||
Study Groups/Cohorts | men or women between 21-84
Multi-analyte blood test screening alone and as combination with multi-analyte Test and Ultrasound in subjects diagnosed with liver cirrhosis
Intervention: Diagnostic Test: Multi-analyte blood Test
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status | Active, not recruiting | ||||||||
Estimated Enrollment |
1600 | ||||||||
Original Estimated Enrollment |
1578 | ||||||||
Estimated Study Completion Date | June 30, 2024 | ||||||||
Actual Primary Completion Date | February 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender |
|
||||||||
Ages | 21 Years to 84 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03694600 | ||||||||
Other Study ID Numbers | LAM-2018-01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | Helio Genomics | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | Helio Genomics | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
|
||||||||
PRS Account | Helio Genomics | ||||||||
Verification Date | September 2023 |