Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2025-12-17 @ 8:06 AM
Study NCT ID:
NCT04468841
Status:
None
Last Update Posted:
2025-08-19 00:00:00
First Post:
2020-07-09 00:00:00
Brief Title:
Measuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
An Exploratory Study to Correlate the Level of Cell-free DNA With Response to First-line Treatment in Patients With Follicular Lymphoma
Status:
None
Status Verified Date:
2025-08
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 is a non-therapeutic protocol aimed to assess the ability of the s cfDNA assay to detect clinical response in FL when compared to conventional approaches for assessing response, such as PET-CT scans.
Study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For patients who receive RT, peripheral blood samples will be collected before initiation of RT, and then 3 months, 6 months, 12 months, 18 months and 24 months post RT using a s cfDNA assay.
Study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For patients who receive RT, peripheral blood samples will be collected before initiation of RT, and then 3 months, 6 months, 12 months, 18 months and 24 months post RT using a s cfDNA assay.
Detailed Description:
This is a non-therapeutic protocol aimed to assess the ability of the s cfDNA assay to detect clinical response in FL when compared to conventional approaches for assessing response such as PET-CT scans
Study assessments will include 1 identification of the mutations present in the primary tumor 2 identification of these mutations in the peripheral blood samples collected before initiation of standard therapy after 2 cycles of therapy at the completion of 6-8 cycles of induction therapy and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay For patients who receive RT peripheral blood samples will be collected before initiation of RT and then 3 months 6 months 12 months 18 months and 24 months post RT using a s cfDNA assay
Study assessments will include 1 identification of the mutations present in the primary tumor 2 identification of these mutations in the peripheral blood samples collected before initiation of standard therapy after 2 cycles of therapy at the completion of 6-8 cycles of induction therapy and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay For patients who receive RT peripheral blood samples will be collected before initiation of RT and then 3 months 6 months 12 months 18 months and 24 months post RT using a s cfDNA assay
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