Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04943198
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2021-06-21
Brief Title:
Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis
Sponsor:
Anna Raciborska
Organization:
Institute of Mother and Child Warsaw Poland
Study Overview
Official Title:
Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis
Status:
RECRUITING
Status Verified Date:
2024-01
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:
BRAVO
Brief Summary:
Prospective interventional open randomized single-center non-commercial clinical trial to optimize treatment and dosage of vemurafenib in juvenile patients with histiocytosis resistant to conventional therapy and in whom the BRAF gene mutation has been found
Detailed Description:
BRAVO clinical study is part of the POLHISTIO project The POLHISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis The project objectives are defined as follows 1 to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA 2 to compare molecular test results with clinical data 3 to evaluate the diagnostic usefulness of the status of molecular analysis MRD as a prognostic factor compared with other recognized factors 4 in the case of failure of conventional therapy - to modify treatment and to apply targeted treatment based on molecular status of gene mutation The project is intended to include patients from all over Poland
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