Ignite Creation Date:
2024-05-06 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03375437
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-10
First Post:
2017-12-04
Brief Title:
RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK123 ROS1 or ALK Gene Fusions
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK123 ROS1 or ALK Gene Fusions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
RNASARC
Brief Summary:
This trial is a multicenter prospective cohort study aiming to describe molecular profiles of soft tissue sarcoma STS with complex genomic profiles in particular to assess the incidence of NTRK123 ROS1 or ALK gene fusions to direct such patients through an ongoing clinical trial with entrectinib when appropriate An exploratory translational program is also correlated to this trial in order to analyse immune gene expression
Detailed Description:
Following inform consent form ICF signature a formalin-fixed and paraffin-embedded FFPE tumor block archival or a dedicated freshly collected tumor biopsy will be collected for all enrolled patients and centralized at the biological resources platform of the Centre Léon Bérard
At reception a central pathological review will be performed to confirm if quality and quantity of material is acceptable all tumor sample should present at least 20 ideally 30 of tumor cells and have a surface area 5 mm2 optimal condition is a surface area of 5-25 mm2 If the quality and quantity of tumor sample do not meet the standards patients will be considered as screening failure If standards are met inclusion will be confirmed and molecular screening will be initiated as well as the translational research program
The molecular screening to detect NTRK123 ROS1 or ALK gene rearrangements will be a two-step process consisting of
1 First immunohistochemistry IHC assay to detect protein expression of TRKABC encoded by NTRK123 ROS1 or ALK Only positive IHC samples will continued the 2nd step of molecular screening Negative IHC patients do not require further NTRK ROS or ALK gene rearrangement testing however tumor samples will be further used for additional translational research program presented in Section VII and data about the clinical evolution of these patients will be collected
2 Second RNAseq analysis will be performed on positive IHC specimens to detect specific rearrangements in the NTRK1NTRK2 NTRK3 ROS1 or ALK genes
3 Following molecular analyses screening results will be immediately within 24 hours communicated to investigators GSF-GETO Network and Ignyta representatives in order to recommend patients with NTRK1 NTRK2 NTRK3 ROS1 or ALK rearrangement for formal eligibility determination for potential enrolment in a clinical trial in particular with entrectinib STARTRK-2 NCT02568267
At reception a central pathological review will be performed to confirm if quality and quantity of material is acceptable all tumor sample should present at least 20 ideally 30 of tumor cells and have a surface area 5 mm2 optimal condition is a surface area of 5-25 mm2 If the quality and quantity of tumor sample do not meet the standards patients will be considered as screening failure If standards are met inclusion will be confirmed and molecular screening will be initiated as well as the translational research program
The molecular screening to detect NTRK123 ROS1 or ALK gene rearrangements will be a two-step process consisting of
1 First immunohistochemistry IHC assay to detect protein expression of TRKABC encoded by NTRK123 ROS1 or ALK Only positive IHC samples will continued the 2nd step of molecular screening Negative IHC patients do not require further NTRK ROS or ALK gene rearrangement testing however tumor samples will be further used for additional translational research program presented in Section VII and data about the clinical evolution of these patients will be collected
2 Second RNAseq analysis will be performed on positive IHC specimens to detect specific rearrangements in the NTRK1NTRK2 NTRK3 ROS1 or ALK genes
3 Following molecular analyses screening results will be immediately within 24 hours communicated to investigators GSF-GETO Network and Ignyta representatives in order to recommend patients with NTRK1 NTRK2 NTRK3 ROS1 or ALK rearrangement for formal eligibility determination for potential enrolment in a clinical trial in particular with entrectinib STARTRK-2 NCT02568267
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