Clinical trial NCT03347318: Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease
Official title: Non-interventional Study for the Determination of Molecular Resistance Profiling to Targeted Therapies in Patients With Neoplastic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Tumors
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with selected solid tumors (CRC, Prostate Cancer, Head \& Neck Cancer, Gastric Cancer, Glioblastoma, Breast Cancer, Hepatocarcinoma, Biliary Tract Carcinoma, Lung Cancer, Rare Tumors, Metastatic Sarcoma and Metastatic Melanoma).

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: number of patient correctly sampled
timeFrame: through study completion, an average of five years
Secondary outcomes:
measure: number of patients with detected genetic alterations that respond to treatments assigned by physician.
timeFrame: through study completion, an average of five years
Other outcomes:
Locations:
city: Aosta
country: Italy
facility: Ospedale Regionale Umberto Parini
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi
city: Candiolo
country: Italy
facility: Istituto Di Candiolo - Fondazione Del Piemonte Per L'Oncologia (FPO-Irccs)
city: Genova
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: Azienda Ospedaliera Niguarda Ca'Granda
city: Milan
country: Italy
facility: IEO - Istiuto Europeo di Oncologia
city: Orbassano
country: Italy
facility: AOU S. Luigi Gonzaga
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Turin
country: Italy
facility: A.O. Città della Salute e della Scienza di Torino - Presidio ospedaliero Ostetrico Ginecologico Sant'Anna
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Molinette
city: Turin
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Turin
country: Italy
facility: Presidio Ospedaliero Martini
Study officials:
References: