Clinical trial NCT03350412: Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
Official title: Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: FUNNEL population consists of individual at least 18 years of age with newly diagnosed metastatic colorectal carcinoma at the first sign of metastasis (adjuvant relapse or first diagnosis)

Brief summary: The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
* Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital.
* Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year.
* Age ≥18.
* ECOG PS 0-1.
* No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
* Signed informed consent.

Exclusion Criteria:

* Symptomatic brain metastases.
* Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption.
* History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years.
* No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.

Primary outcomes:
measure: Thoroughness to report molecular profiling
timeFrame: 14 days from sample acquisition
Secondary outcomes:
measure: Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC
timeFrame: 24 months from first patient in.
measure: Percentage of complete data capture for treatment-related check-point events
timeFrame: through study completion, an average of five years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: AOU Policlinico S Orsola - Malpighi
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
Study officials:
affiliation: Fondazione del Piemonte per l'Oncologia
name: Massimo Aglietta, md
role: PRINCIPAL_INVESTIGATOR
References: