Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424684
Status:
WITHDRAWN
Last Update Posted:
2020-05-07
First Post:
2007-01-18
Brief Title:
Comparison of the Quantiferon-TB GOLD in Tube Assay With Tuberculin Skin Testing for Detecting Latent Tuberculosis Infection in Patients With Chronic Liver Disease Being Evaluated for or Awaiting Liver Transplantation
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Comparison of the Quantiferon-TB GOLD in Tube Assay With Tuberculin Skin Testing for Detecting Latent Tuberculosis Infection in Patients With Chronic Liver Disease Being Evaluated for or Awaiting Liver Transplantation
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to obtain contract with sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tuberculosis TB is an important cause of morbidity and mortality in organ transplant recipients Management of tuberculosis in this setting is challenging due to the complexity of diagnosis and the potential toxicity of anti-TB therapy especially in liver transplant candidates and recipients Although the tuberculin skin test TST is recommended for screening of latent tuberculosis infection LTBI in all candidates for liver transplantation the performance of the TST in this setting is less than optimal due to a lack of specificity false-positive results due to interaction with BCG vaccine and other mycobacterial infections and a lack of sensitivity in a population that is relatively immunocompromised Recently a new test named QuantiFERON-TB Gold QFT-G has been approved for the diagnosis of LTBI QFT-G detects the release of interferon-gamma IFN-γ by sensitized white cells after incubation of whole blood with TB antigens QFT-G is expected to be more specific than TST However there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease We hypothesize that the QFT-G test will correlate better with the risk of LTBI This study advances research on the prevention of a serious bacterial infection that can have devastating consequences in the post-transplant setting The new diagnostic strategy may more accurately determine the presence of LTBI thereby allowing appropriate therapy
Detailed Description:
Review and record the results of the testprocedures x-rays CT-scans etc that are part of the subjects clinical care and the results will become part of the research record In addition laboratory results liver function tests chemistry CBC with diff PT and INR or PTT will be collected from the medical record
Record the list of medications the subject is taking Collect information on demographics address phone number etc including gender race and ethnicity
Review and record past medical and social history
The screening procedures will take a total of about 15-30 minutes and all subjects will be seen in the Liver Transplant Clinic The investigator and research coordinators will be reviewing the subjects medical record to collect the required information about the subjects medical history We will ask the subject if it cannot be found in the medical record about past TB exposure and treatment overseas travel and current resident status long term care facility home hospital etc
If the subject qualifies for the research study the subject will undergo the experimental procedures listed below These procedures will take place during the visit in the Liver Transplant Clinic
As part of the liver transplant evaluation subjects will have blood withdrawn for different types of testing When the blood is obtained we will collect about 3cc of blood for the new TB testing This collection of the blood sample will occur while the subject is getting their required pre transplant blood work so that they will not need to get stuck twice with a needle The results of this research testing will not be available to the subject or physicians but will be compared
The QuantiFERON-TB Gold IT system uses specialized blood collection tubes which are used to collect whole blood Incubation of the blood occurs in the tubes for 16 to 24 hours after which plasma is harvested and tested for the presence of IFN-g produced in response to the peptide antigens
The QFT-G IT assay will be performed according to the manufacturers instructions Cellestis Ltd One mL of whole blood is placed in three separate test tubes one containing no antigen nil control one with TB antigens ESAT-6 CFP-10 and TB77 and one with phytohemaglutinin mitogen or positive control The three tubes will be incubated as soon as possible after collection within 16hrs and will incubate for 16 to 24 hours at 37C Following this incubation period the tubes will be centrifuged The plasma will be removed from the tube and placed in a plasma storage container These containers will then be frozen for future IFN-γ measurement by ELISA Each institution will perform testing up to this point in the process Each month plasma samples will be posted on ice to Edmonton Hospital in Alberta Canada The samples will be batched and then undergo the ELISA testing process according to the manufacturers instructions
A result of 035 IUmL in the TB antigen tube will be considered a positive result If the level is less than this and the mitogen control is positive 05 IUmL a negative result will be recorded If the level in both the TB antigen and mitogen tube is less than the threshold for positive then an indeterminate anergic result will be recorded The nil antigen tube adjusts for background IFN-γ levels and is subtracted from the IFN-γ level for the TB antigen and mitogen tube
Once we have collected the blood sample the subject will have completed the study
Record the list of medications the subject is taking Collect information on demographics address phone number etc including gender race and ethnicity
Review and record past medical and social history
The screening procedures will take a total of about 15-30 minutes and all subjects will be seen in the Liver Transplant Clinic The investigator and research coordinators will be reviewing the subjects medical record to collect the required information about the subjects medical history We will ask the subject if it cannot be found in the medical record about past TB exposure and treatment overseas travel and current resident status long term care facility home hospital etc
If the subject qualifies for the research study the subject will undergo the experimental procedures listed below These procedures will take place during the visit in the Liver Transplant Clinic
As part of the liver transplant evaluation subjects will have blood withdrawn for different types of testing When the blood is obtained we will collect about 3cc of blood for the new TB testing This collection of the blood sample will occur while the subject is getting their required pre transplant blood work so that they will not need to get stuck twice with a needle The results of this research testing will not be available to the subject or physicians but will be compared
The QuantiFERON-TB Gold IT system uses specialized blood collection tubes which are used to collect whole blood Incubation of the blood occurs in the tubes for 16 to 24 hours after which plasma is harvested and tested for the presence of IFN-g produced in response to the peptide antigens
The QFT-G IT assay will be performed according to the manufacturers instructions Cellestis Ltd One mL of whole blood is placed in three separate test tubes one containing no antigen nil control one with TB antigens ESAT-6 CFP-10 and TB77 and one with phytohemaglutinin mitogen or positive control The three tubes will be incubated as soon as possible after collection within 16hrs and will incubate for 16 to 24 hours at 37C Following this incubation period the tubes will be centrifuged The plasma will be removed from the tube and placed in a plasma storage container These containers will then be frozen for future IFN-γ measurement by ELISA Each institution will perform testing up to this point in the process Each month plasma samples will be posted on ice to Edmonton Hospital in Alberta Canada The samples will be batched and then undergo the ELISA testing process according to the manufacturers instructions
A result of 035 IUmL in the TB antigen tube will be considered a positive result If the level is less than this and the mitogen control is positive 05 IUmL a negative result will be recorded If the level in both the TB antigen and mitogen tube is less than the threshold for positive then an indeterminate anergic result will be recorded The nil antigen tube adjusts for background IFN-γ levels and is subtracted from the IFN-γ level for the TB antigen and mitogen tube
Once we have collected the blood sample the subject will have completed the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None