Ignite Creation Date:
2024-05-05 @ 9:31 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00904956
Status:
UNKNOWN
Last Update Posted:
2011-07-11
First Post:
2009-05-18
Brief Title:
Study of Latent Tuberculosis Infection LTBI by High Resolution Scanner
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Study of Latent Tuberculosis Infection LTBI by High Resolution Scanner
Status:
UNKNOWN
Status Verified Date:
2009-11
Last Known Status:
RECRUITING
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:
GRANLATHU
Brief Summary:
It is traditionally considered that someone with a positive tuberculin skin test TST andor positive result in Cell Interferon-Gamma Release Assay TIGRA depending on the different countries guidelines is infected but not ill when the absence of lesions is demonstrated in a thorax X-Ray assay Even though the experiences described in literature using cows and pigs as animal models for the study of LTBI demonstrate the presence of this kind of lesion in the animals even too small to be detected by X-Ray assay which would suggest they also could happen in human LTBI Nowadays the High Resolution Scanners HR TC offer the possibility of detecting any lesion approximately 1 mm in diameter so the investigators plan to use this technique to screen people already infected by M tuberculosis but not ill following the Diagnosis Standard Guidelines
Additional pathological analysis of resected and post-mortem tissues will provide lesion-based profiles of humans infected with tuberculosis
Additional pathological analysis of resected and post-mortem tissues will provide lesion-based profiles of humans infected with tuberculosis
Detailed Description:
It is traditionally considered that the development of LTBI is due to the M tuberculosis ability to develop a dormancy state within well-structured lesions granulomas which can remain in the lung of the host even for life The investigators have developed a new original hypothesis based on scientific evidence that takes into account the idea that a lesion cannot be held forever because the host tends to remove any lesion in order to rebuild the original parenchyma in a healing process Even if M tuberculosis can remain in a dormantnon-replicating state for a long period this is an important but not sufficient factor to explain the LTBI The Dynamic Hypothesis tries to explain the existence of LTBI in spite of the healing process that could remove it by a constant reinfection of the hosts tissue
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