Status:
COMPLETED
Biomarker Analysis for Patients With Metastatic Colorectal Cancer (MCC)
Lead Sponsor:
US Oncology Research
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Colorectal Neoplasms
Advanced Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Patients are being asked to participate in this study who have colorectal cancer that has come back after initial treatment. The investigators want to improve treatment in patients with this disease. ...
Detailed Description
This is a short-term, prospective, feasibility study to determine how effectively investigators can obtain biomarker analysis on patients with mCRC from whom informed consent and authorization will be...
Eligibility Criteria
Inclusion
- Has been re-staged to Stage IV colorectal cancer following recurrence after adjuvant chemo-therapy treatment for Stage II or III disease
- Primary tumor has been resected prior to the patient being diagnosed with Stage IV disease
- Able to submit archival tissue from the patient's resected primary tumor taken prior to diagnosis of metastatic disease
- Tumor tissue (biopsy or surgery) was retrieved within 4 weeks from the date of signing the ICF and tested as outlined in the protocol:
- • FFPE specimen (blocks or cut slides) currently in storage at a pathology lab. Such tissue may be archival and stored, for no more than 5 years, being obtained at the time for a standard of care diagnostic or research biopsy.
- Is at least 18 years old
- Is willing to allow access to clinical and demographic information
- Has signed a Patient Informed Consent Form
- Has signed a Patient Authorization Form (HIPAA)
Exclusion
- Is unable or unwilling to provide informed consent for collection and profiling of tumor tissue
- PATIENT HAS NOT RECEIVED PRIOR ADJUVANT TREATMENT FOR STAGE II OR III COLORECTAL CANCER OR HAS BEEN ORIGINALLY DIAGNOSED WITH STAGE IV
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01909362
Start Date
July 1 2013
End Date
February 1 2014
Last Update
February 26 2014
Active Locations (1)
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1
13 sites within US
Incl Greenville, SC and Tyler, TX, Texas, United States