Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04959890
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2021-06-21
Brief Title:
Methodology Study of Retroviral Insertion Site Analysis in Strimvelis Gene Therapy
Sponsor:
Fondazione Telethon
Organization:
Fondazione Telethon
Study Overview
Official Title:
Methodology Study to Investigate the Utility of Retroviral Insertion Site Analysis in Samples From Subjects Treated With Strimvelis Gene Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This study is a post approval commitment to evaluate the accuracy and precision of retroviral insertion site RIS analysis and its utility for investigating and predicting the potential for insertional oncogenesis in subjects treated with Strimvelis
Detailed Description:
This non-interventional retrospective methodology study will use peripheral blood and bone marrow samples previously taken from subjects treated with Strimvelis The study does not require subjects to undergo any further treatment intervention or blood withdrawal
The objective of this methodology study is to evaluate the accuracy and precision of shearing extension primer tag selection ligation-mediated polymerase chain reaction S-EPTSLM-PCR for RIS analysis and its utility for investigating and predicting the potential for insertional oncogenesis in subjects previously treated with Strimvelis for severe combined immunodeficiency SCID due to adenosine deaminase ADA deficiency
The objective of this methodology study is to evaluate the accuracy and precision of shearing extension primer tag selection ligation-mediated polymerase chain reaction S-EPTSLM-PCR for RIS analysis and its utility for investigating and predicting the potential for insertional oncogenesis in subjects previously treated with Strimvelis for severe combined immunodeficiency SCID due to adenosine deaminase ADA deficiency
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