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

Sarcoma Clinical Trial

— PROGEN_SARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076070
• Other study ID #: RS1607/21
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: May 25, 2024

Study information

• Verified date: June 2023
• Source: Regina Elena Cancer Institute
• Contact: Virginia Ferraresi, MD
• Phone: 0652665144
• Email: virginia.ferraresi[@]ifo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Sarcoma

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (10)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Candiolo Cancer Institute - IRCCS, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituti Tumori Giovanni Paolo II, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Istituto Oncologico Veneto IRCCS, Istituto Ortopedico Rizzoli, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori, Ospedale Pediatrico Bambin Gesù

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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