RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions. (RNASARC)

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    750
  • sponsor
    Centre Leon Berard
Updated on 27 February 2022
x-rays
metastasis
tumor cells
ROS1
cancer treatment
eosin
angiosarcoma
fibrosarcoma
soft tissue sarcoma
liposarcoma
undifferentiated pleomorphic sarcoma
leiomyosarcoma
mpnst
malignant peripheral nerve sheath tumor

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 NTRK1/2/3, 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.

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 NTRK1,2,3, ROS1 or ALK gene rearrangements will be a two-step process, consisting of :

  1. 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
  2. Second, RNAseq analysis will be performed on positive IHC specimens to detect specific rearrangements in the NTRK1,NTRK2, 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).

Details
Condition Soft Tissue Sarcoma, Advanced Cancer, Metastatic Cancer
Treatment Blood and tumor samples
Clinical Study IdentifierNCT03375437
SponsorCentre Leon Berard
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

I1. Male or female patients aged ≥ 12 years at time of informed consent form (ICF) signature
I2. Histologically confirmed diagnosis of advanced /metastatic disease STS with complex genomics (e.g., Leiomyosarcoma [LMS], Undifferentiated Pleomorphic Sarcoma [UPS], pleomorphic liposarcoma/rhabdomyosarcoma [P-LPS/P-RMS], angiosarcoma, malignant peripheral nerve sheath tumor [MPNST], myxofibrosarcoma, fibrosarcoma)
I3. Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological
report
either a tumor archival block (less than 3 years old) or a dedicated freshly collected de
novo biopsy performed from one accessible lesion visible by medical imaging and accessible
to percutaneous sampling with a diameter of at least 10 mm
I4. Tumor sample meeting following quality/quantity control (QC) criteria confirmed by
a central pathological review
at least 20% (ideally 30%) of tumor cells and a sample size surface area > 5mm2 (ideally
-25mm2)
I5. Patient (and legal guardians if not-emancipated minor) should understand, sign
and date the written voluntary informed consent form prior to any protocol-specific
I6. Patient must be covered by a medical insurance
procedures performed. Patient should be able and willing to comply with study
Non-inclusion criteria
procedures as per protocol
NI1. Patients with non-assessable tumor sample
NI3. Pregnant or breast-feeding patients
NI2. Prior treatment with approved or investigational TRK, ROS1, or ALK inhibitors
Any other prior anticancer therapy are allowed with no limit of prior number of
treatment lines
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