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

Recruiting

• Conditions: Sarcoma

• Registration Number: NCT06076070
• Lead Sponsor: Regina Elena Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-25
• Study First Submitted: 2023-03-29
• Status Verified: 2023-06
• Study First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-05-25
• Study Completion: 2024-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Sarcoma patients of any age (inclusion of centers pediatric)
• 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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extended molecular profile	Baseline	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).
Evaluate interest and feasibility in carrying out genomic profilingfor building two databases data collection	Baseline	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.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy