Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

NCT ID: NCT03350412

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Massimo Aglietta, md

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia

Locations

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AOU Policlinico S Orsola - Malpighi

Bologna, , Italy

Site Status RECRUITING

Policlinico S.Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

Fondazione del Piemonte per l'Oncologia

Candiolo, , Italy

Site Status RECRUITING

IOV - Istituto Oncologico Veneto

Padua, , Italy

Site Status RECRUITING

Policlinico Universitario Campus Biomedico

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Aglietta, md

Role: CONTACT

Facility Contacts

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Andrea Ardizzoni, MD

Role: primary

Andrea Ardizzoni, MD

Role: primary

Francesco Leone, MD

Role: primary

Vittorina Zagonel, MD

Role: primary

Giuseppe Tonini, MD

Role: primary

Other Identifiers

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007-IRCC-10IIS-14

Identifier Type: -

Identifier Source: org_study_id

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