Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease

Solid Tumors Clinical Trial

— PROFILING  

Official title:

Non-interventional Study for the Determination of Molecular Resistance Profiling to Targeted Therapies in Patients With Neoplastic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03347318
• Other study ID #: 001-IRCC-00IIS-10
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: November 17, 2017
• Start date: January 2011
• Est. completion date: December 2021

Study information

• Verified date: July 2017
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Silvia Marsoni, MD
• Email: silvia.marsoni[@]ircc.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2021
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Locations

Country	Name	City	State
Italy	Ospedale Regionale Umberto Parini	Aosta
Italy	Policlinico S.Orsola Malpighi	Bologna
Italy	Istituto Di Candiolo - Fondazione Del Piemonte Per L'Oncologia (FPO-Irccs)	Candiolo
Italy	Azienda Ospedaliero-Universitaria Careggi	Genova
Italy	Azienda Ospedaliera Niguarda Ca'Granda	Milan
Italy	IEO - Istiuto Europeo di Oncologia	Milan
Italy	Fondazione IRCCS - Istituto Nazionale dei Tumori	Milano
Italy	AOU S. Luigi Gonzaga	Orbassano
Italy	IOV - Istituto Oncologico Veneto	Padova
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
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	AOU Città della Salute e della Scienza di Torino - Presidio Molinette	Turin
Italy	Ospedale Mauriziano Umberto I	Turin
Italy	Presidio Ospedaliero Martini	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patient correctly sampled	number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients.	through study completion, an average of five years
Secondary	number of patients with detected genetic alterations that respond to treatments assigned by physician.		through study completion, an average of five years