Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515860
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Neurofibromatosis Type 1 Tumor Early Detection Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observational Trial of Liquid Biopsy for Malignant Peripheral Nerve Sheath Tumor MPNST Among Participants With Neurofibromatosis Type 1
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NF1-TED
Brief Summary:
The goal of this observational study is to determine if a liquid biopsy ie blood test is an effective clinical tool for monitoring the development of malignant peripheral nerve sheath tumor MPNST among adults 18 years and older with Neurofibromatosis Type 1 NF1 compared to the current standard of care The main questions it aims to answer are
How effective is liquid biopsy compared to the current standard of care clinical surveillance and imaging for early detection of MPNST development among people with NF1 Can liquid biopsy offer a cost-effective method for early detection of MPNST in people with NF1 Also can liquid biopsy provide earlier detection that potentially leads to better outcomes Also can offering liquid biopsy improve access to care for people experiencing barriers to access such as minority populations or people in rural areas
At baseline participants will be asked to
Complete surveys to provide their demographic and NF1-related health information
Report whether or not they are experiencing MPNST-related symptoms
Provide blood samples 15 mL blood total between three tubes which is approximately one tablespoon
Every six months during the five-year follow-up period participants will be asked to
Complete additional surveys to report whether or not they are experiencing MPNST-related symptoms andor if they have been diagnosed with a new MPNST
Provide an additional blood sample 10 mL blood total in one tube
If diagnosed with an MPNST by their healthcare provider during the follow-up period participants will be asked to
Complete an additional survey regarding their diagnosis and symptoms
Provide an additional blood sample 10 mL blood in one tube
In parallel the study team will request a sample of tumor tissue from the care provider if available
How effective is liquid biopsy compared to the current standard of care clinical surveillance and imaging for early detection of MPNST development among people with NF1 Can liquid biopsy offer a cost-effective method for early detection of MPNST in people with NF1 Also can liquid biopsy provide earlier detection that potentially leads to better outcomes Also can offering liquid biopsy improve access to care for people experiencing barriers to access such as minority populations or people in rural areas
At baseline participants will be asked to
Complete surveys to provide their demographic and NF1-related health information
Report whether or not they are experiencing MPNST-related symptoms
Provide blood samples 15 mL blood total between three tubes which is approximately one tablespoon
Every six months during the five-year follow-up period participants will be asked to
Complete additional surveys to report whether or not they are experiencing MPNST-related symptoms andor if they have been diagnosed with a new MPNST
Provide an additional blood sample 10 mL blood total in one tube
If diagnosed with an MPNST by their healthcare provider during the follow-up period participants will be asked to
Complete an additional survey regarding their diagnosis and symptoms
Provide an additional blood sample 10 mL blood in one tube
In parallel the study team will request a sample of tumor tissue from the care provider if available
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None