Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 1:16 PM
Study NCT ID:
NCT03160768
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Isolating P16 Expression
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Feasibility of Isolating P16 Expression
Status:
COMPLETED
Status Verified Date:
2019-05
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:
Expression of the cell cycle regulator p16INK4a increases with age and toxic stressors. In mice, both radiation and chemotherapy are known to increase p16. Due to its influence on age-related regenerative capacity, p16 is an excellent candidate biomarker of physiologic reserve that may identify patients able to withstand the stressor of chemotherapy (low p16) from those unlikely to tolerate chemotherapy (high p16). That is, expression of p16 may predict physiologic, rather than chronologic, age. Such findings could have implications for care of cancer survivors and treatment decision-making in cancer patients.
STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer during childhood.
STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer during childhood.
Detailed Description:
At St. Jude Children's Research Hospital, survivors who meet the eligibility criteria will be identified from SJLIFE protocol participants. After signing consent, the subject will have a blood specimen collected at the same time as the blood draw for the SJLIFE protocol. These samples will have T cell isolation performed then placed on ice and stored until batch shipment for investigation of p16 expression.
Study Oversight
Has Oversight DMC:
False
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?: