Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease

• Conditions: Solid Tumors

• Registration Number: NCT03347318
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Brief Summary

The main purpose of this study is to define the molecular profile of selected solid tumors. From each participants will be collected biological materials for molecular analysis, including saliva, blood and vital tumor tissue derived form surgical or biopsy procedures. Whereas possible, vital tumor specimens will be inoculated and propagated in immunocompromised NOD/SCID mice to study the genetic correlations between genetic status and response to target drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-11-17
• Last Update Submitted: 2017-11-17
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20
• Primary Completion: 2018-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Patients with at least one of the following selected solid tumors:

• Colorectal Cancer (primary or with synchronous/metachronous liver metastases)
• Prostate Cancer
• Head & Neck Tumors
• Gastric Cancer
• Glioblastoma
• Breast Cancer
• Hepatocarcinoma
• Biliary Tract Carcinoma
• Lung Cancer (primary)
• Rare Tumors (incidence ≤ 5x10-6)
• Metastatic Sarcoma
• Metastatic Melanoma

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patient correctly sampled	through study completion, an average of five years	number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients.

Secondary Outcome Measures

Name	Time	Method
number of patients with detected genetic alterations that respond to treatments assigned by physician.	through study completion, an average of five years

Trial Locations

Locations (15)

Policlinico S.Orsola Malpighi; 🇮🇹 Bologna, Italy

Istituto Di Candiolo - Fondazione Del Piemonte Per L'Oncologia (FPO-Irccs); 🇮🇹 Candiolo, Italy

Ospedale Regionale Umberto Parini; 🇮🇹 Aosta, Italy

IEO - Istiuto Europeo di Oncologia; 🇮🇹 Milan, Italy

IOV - Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Molinette; 🇮🇹 Turin, Italy

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Genova, Italy

Fondazione IRCCS - Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Azienda Ospedaliera Niguarda Ca'Granda; 🇮🇹 Milan, Italy

AOU S. Luigi Gonzaga; 🇮🇹 Orbassano, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Ospedale Mauriziano Umberto I; 🇮🇹 Turin, Italy

Policlinico Universitario Campus Biomedico; 🇮🇹 Roma, Italy

A.O. Città della Salute e della Scienza di Torino - Presidio ospedaliero Ostetrico Ginecologico Sant'Anna; 🇮🇹 Turin, Italy

Presidio Ospedaliero Martini; 🇮🇹 Turin, Italy