Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263530
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-11-14
Brief Title:
Prognostic Significance of ctDNA in HL
Sponsor:
Interni hematologicka klinika FNKV
Organization:
Interni hematologicka klinika FNKV
Study Overview
Official Title:
Prognostic Significance of Circulating Tumor DNA in Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL eg age 60 and 60 years EBV These mutations will be correlated with response to the treatment in the first line in the relapse during brentuximab vedotin andor nivolumab treatment Circulating tumor DNA will be correlated with the extent of tumor mass and chemoradiotherapy
Detailed Description:
Samples of plasma from peripheral blood will be taken for investigational ctDNA examination during the specific timepoints at diagnosis after 2 cycles of initial chemotherapy at the end of chemotherapy 3 months after radiotherapy at the diagnosis of the first relapse after salvage chemotherapy before ASCT 3 months after ASCT at the diagnosis of second relapse and every 3 months during brentuximab vedotin treatment or during nivolumab treatment until progression The buccal swab for germline DNA extraction will be performed at the time of enrollment into the study Samples of peripheral blood for EBV-DNA analysis will be obtained from the EBV-positive cHL patients to measure EBV load at the same time-points as ctDNA Microdissected HRS cells from fresh frozen biopsies at the diagnosis and at the relapse will be used for tumor cells next generation sequencing
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