GENomic PROfilation for Therapeutic Purposes in SARComas and Molecular Tumor Board (MTB): Retrospective/Prospective Study in Referral Centers

NCT06076070 | Unknown

• 1 other identifier: RS1607/21
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter noninterventional, translational study, retrospective/prospective designed in order to assess the aptitude to the use of genomic profiling methods for therapeutic purposes and evaluation by the institutional Molecular Tumor Board (MTB) of sarcoma patients with metastatic/locally advanced disease that is inoperable with no viable therapeutic alternatives or with histotypes known to be resistant to available in-label medical treatments and without already therapeutically validated driver mutations.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (2)

• Evaluate interest and feasibility in carrying out genomic profilingfor building two databases data collection

  Specific center database: Existence or otherwise of an MTB in the participating structure, composition of the MTB, methods of access to off-label drugs used by the centre, management of incidental findings. Patient specific database: Identification code, demographic data (age, ethnic origin), histological diagnosis, date of onset disease, stage of disease, any molecular tests performed to define the histotype diagnosis, adjuvant therapy, number of antineoplastic treatments carried out for the disease advanced, date of last recurrence of disease, molecular profile identified, date of presentation to MTB, type of molecular analysis required by MTB, presence or absence of therapeutic target e description of the target identified if present, type of treatment undertaken following the analysis genomics, method of access to the drug for the specific patient, starting date of treatment on a basis molecular, response to treatment, progression-free survival, overall survival.

  Baseline

• Extended molecular profile

  Analysis of the inclusion of tissue in FFPE relating to the neoplasm under examination. RNA and DNA extraction from FFPE tissue will be performed using the kits dedicated qiagen. The NGS analysis will be carried out using a panel of 500 genes, described as oncogenic drivers, starting from 20 ng of nucleic acid, using preparation reagents of the libraries and for sequencing the OCA PLUS Thermofisher Scientific kit, following the protocols indicated by the manufacturer. The same kit allows the evaluation tumor mutational burden (TMB), microsatellite instability (MSI) and gene defects PROGEN\_SARC Version no. 2.0 - 14.06.2022 11/15 of homologous recombination (HRR) including loss of heterozygosity (LOH).

  Baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multicenter noninterventional, translational study, retrospective/prospective designed in order to assess the aptitude to the use of genomic profiling methods for therapeutic purposes and evaluation by the institutional Molecular Tumor Board (MTB) of sarcoma patients with metastatic/locally advanced disease that is inoperable with no viable therapeutic alternatives or with histotypes known to be resistant to available in-label medical treatments and without already therapeutically validated driver mutations.

You may qualify if:

• Patients with any histotype of soft tissue sarcomas and bone
• Patients at any stage of the treatment pathway for disease that is localized or metastatic/inoperable
• Availability of follow-up data
• Written informed consent (prospective part/patients in follow-up)

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Candiolo Cancer Institute - IRCCS: collaborator
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator
• Istituto Oncologico Veneto IRCCS: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Istituto Ortopedico Rizzoli: collaborator
• Ospedale Pediatrico Bambin Gesù: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator
• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Virginia Ferraresi, MD

CONTACT

0652665144; virginia.ferraresi@ifo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: October 10, 2023
• Study Start: May 25, 2022
• Primary Completion: May 25, 2024
• Study Completion: May 25, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-06

Locations

IT (1)