Pharmacogenomics in optimizing the chemotherapy in the treatment of colorectal carcinoma - AOBS-FOBERL-COBIOMAR
- Conditions
- COLORECTAL NEOPLASTIC DISEASEMedDRA version: 9.1Level: LLTClassification code 10009973MedDRA version: 9.1Level: LLTClassification code 10009974
- Registration Number
- EUCTR2010-019805-41-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
? Male or female > 18 years ? Histological diagnosis of colon or rectum adenocarcinoma ? Locally advanced or metastatic colorectal carcinoma candidate for chemotherapy and/or target therapy ? Signed informed consent ? Availability to reach the hospital
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
? Lack of histological diagnosis of colon or rectum adenocarcinoma ? Lack of signed informed consent ? < 18 years ? Any other cancer except melanoma or cervical carcinoma in situ ? Previous chemotherapy treatment ? Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ? Identification of a correlation between the biomarker pattern of expression and the disease progression ? Median duration of response to the therapy ? Progression free survival (PFS) ? Overall survival (OS);Primary end point(s): ? Identification of biomarkers able to predict the therapy responsiveness in patients with colorectal carcinoma;Main Objective: ? Identification of biomarkers able to predict the therapy responsiveness in patients with colorectal carcinoma
- Secondary Outcome Measures
Name Time Method