Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2020-06-22
Brief Title:
Patient Response to Immunotherapy Using Spliceosome Mutational Markers PRISMM
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Remote-Directed Virtual Clinical Trial in Metastatic Solid Tumors to Determine Feasibility of Evaluating Patient Response to Immunotherapy Using Spliceosome Mutational Markers PRISMM
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
PRISMM
Brief Summary:
This study is being done to see if patients with metastatic solid tumors hematologic malignancies and lymphoma excluded who have a specific genetic mutation in patients tumor the SF3B1 U2AF1 or SRSF2 mutation are more likely to respond to immunotherapy agents that are now commercially available
Detailed Description:
This is a non-therapeutic study meaning that while Johns Hopkins is providing a treatment recommendation based on participants genetic information participants and participants oncologist will decide ultimately what to do and participants oncologist will monitor participants day to day care while on therapy Participation involves allowing the investigators access to participants sequencing report and medical records providing a blood sample about 8 tablespoons at baseline and possibly again after three months and answering questionnaires If participants join the study a panel of experts Johns Hopkins Molecular Tumor Board will review participants genetic information participants entered and make a determination regarding treatment recommendation Blood will be collected at baseline irrespective of what treatment is recommended If immunotherapy is recommended the investigators may collect blood again at 3 months Participants and participants oncologist will ultimately decide if participants proceed with the recommend treatment or not the recommendation made from Johns Hopkins is not binding in any way Participants oncologist will continue with usual care according to standard practices while participants are on therapy The investigators will get health information and conduct questionnaires with participants and participants oncologist to assess how participants are doing on therapy The main risks are the discomforts of the blood draw which are expected to be minor and not last boredom from completing questionnaires and the risk that information may become known to people outside of the study Participants may or may not benefit directly from being in the study and there is no payment for participation
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