RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions. (RNASARC)
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|ClinicalTrials.gov Identifier: NCT03375437|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : June 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Advanced Cancer Metastatic Cancer||Genetic: Blood and tumor samples||Not Applicable|
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 NTRK1,2,3, ROS1 or ALK gene rearrangements will be a two-step process, consisting of :
- First, immunohistochemistry (IHC) assay to detect protein expression of TRKA/B/C (encoded by NTRK1,2,3), 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
- Second, RNAseq analysis will be performed on positive IHC specimens to detect specific rearrangements in the NTRK1,NTRK2, NTRK3, ROS1 or ALK genes.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions.|
|Actual Study Start Date :||February 15, 2018|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||January 15, 2021|
|Experimental: NTRK, ROS and ALK molecular screening||
Genetic: Blood and tumor samples
FFPE tumor block (archival or a dedicated freshly collected tumor biopsy) will be collected for all enrolled patients and centralized.
Blood sampling for Translational Research (optional) (2*10mL EDTA)
- the proportion of patients with NTRK1/2/3, ROS1 or ALK gene fusions (95% confidence interval) [ Time Frame: 24 months ]Such molecular pre-screening will allow to direct eligible patients with sarcomas harboring an NTRK1/2/3, ROS1 or ALK fusion to a clinical trial with entrectinib, when judged appropriate by the patient's treating oncologist. Depending of the molecular alterations, other therapeutic options could be envisaged.
- Proportion of patients with NTRK1/2/3, ROS1, or ALK gene fusion per histological sub-types of STS with complex genomics [ Time Frame: 24 months since first inclusion ]the partitioning of STS patients with NTRK1/2/3, ROS1 or ALK gene fusions within the different STS sub-types.
- Clinical characteristics of patients with NTRK1/2/3, ROS1, or ALK gene fusion versus patients with no NTRK1/2/3, ROS1, or ALK gene fusion. [ Time Frame: 24 months since first inclusion ]Comparisons of quantitative variables will be assessed with Student t-test or Wilcoxon-Mann and Whitney test , as appropriate. Comparisons of qualitative variables will be assessed with the X2 test or the Fisher's exact test, as appropriate.
- anti-cancer treatments initiated since inclusion. [ Time Frame: 36 months ]anti-cancer treatments initiated since inclusion among patients with NTRK1/2/3, ROS1, or ALK gene fusion and among patients with no NTRK1/2/3, ROS1, or ALK gene fusion.
- Overall survival (OS) [ Time Frame: 36 months ]Overall survival (OS) among patients with NTRK1/2/3, ROS1, or ALK gene fusion and among patients with no NTRK1/2/3, ROS1, or ALK gene fusion. It will be measured from the date of STS diagnosis to the date of death from any cause. Patients who are alive at the time of analysis will be censored at the date of last contact. OS will be estimated using the Kaplan-Meier method, and will be described in terms of medians along with the associated 2-sided 95% confidence interval (CI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375437
|Contact: Armelle DUFRESNE, MD||(0)4 69 85 61 47 ext +firstname.lastname@example.org|
|Centre Georges-Francois Leclerc||Recruiting|
|Dijon, France, 21079|
|Contact: Nicolas ISAMBERT, MD email@example.com|
|Sub-Investigator: Céline CHARON BARRA, MD|
|Sub-Investigator: Audrey HENNEQUIN, MD|
|Sub-Investigator: Alice HERVIEU, MD|
|Sub-Investigator: Sylvie ZANETTA, MD|
|Centre Oscar Lambret||Recruiting|
|Lille, France, 59000|
|Contact: Nicolas PENEL, MD|
|Principal Investigator: Nicolas PENEL, MD|
|Sub-Investigator: Fredrik LAESTADIUS, MD|
|Sub-Investigator: Diane PANNIER, MD|
|Sub-Investigator: Yves-Marie ROBIN, MD|
|Sub-Investigator: Thomas RYCKEWAERT, MD|
|CHU de Limoges Hôpital Dupuytren||Recruiting|
|Contact: Valérie LEBRUN-LY, MD|
|Principal Investigator: Valérie LEBRUN-LY, MD|
|Sub-Investigator: Sandrine LAVAU-DENES, MD|
|Sub-Investigator: Isabelle POMMEPUY, MD|
|Centre Léon Bérard||Recruiting|
|Lyon, France, 69008|
|Contact: Armelle DUFRESNE, MD|
|Sub-Investigator: Jean-Yves BLAY, MD|
|Sub-Investigator: Mehdi BRAHMI, MD|
|Sub-Investigator: Philippe CASSIER, MD|
|Sub-Investigator: Nadège CORRADINI, MD|
|Sub-Investigator: Isabelle RAY-COQUARD, MD|
|Institut de Cancérologie de la Loire Lucien Neuwirth||Recruiting|
|Contact: Olivier COLLARD, MD firstname.lastname@example.org|
|Principal Investigator: Olivier COLLARD, MD|
|Principal Investigator:||Armelle DUFRESNE, MD||Centre Leon Berard|