Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04557813
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-09-02
Brief Title:
Registry for Molecular Testing Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion
Sponsor:
iOMEDICO AG
Organization:
iOMEDICO AG
Study Overview
Official Title:
Registry for Molecular Testing Treatment and Outcome of Patients With Locally Advanced or Metastatic Solid Tumors Harboring a Fusion of NTRK1 NTRK2 or NTRK3
Status:
ACTIVE_NOT_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:
REALTRK
Brief Summary:
The objective of this registry is to analyze treatment reality and outcome of patients with locally advanced or metastatic solid tumors harboring a fusion of NTRK1 NTRK2 or NTRK3
Detailed Description:
The REALTRK registry will provide data on treatment reality of patients with locally advanced or metastatic solid tumors harboring NTRK1 NTRK2 or NTRK3 gene fusions thereby generating real world evidence It will identify factors that influence treatment decisions after receiving the diagnosis of a NTRK Neurotrophic Tyrosine Receptor Kinase fusion-positive cancer All treatment lines administered before and after the molecular diagnosis of a NTRK fusion-positive cancer irrespective of the type of antineoplastic treatment will be documented Data will be assessed at least 36 months per patient ie until 36 months after inclusion of the last patient in the study This approach will allow a description of TRK fusion protein-targeted therapies and other therapy strategies regarding effectiveness and disease-related symptomology within the limitations of non-randomized studies in terms of comparative analyses Intra-individual and inter-individual comparisons for the latter provided that a sufficient number of patients with a NTRK fusion-positive cancer are not treated with a TRK inhibitor could be performed
The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations
The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations
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