Biomarker Analysis for Patients With Metastatic Colorectal Cancer (MCC)

Completed

Conditions studied: Colorectal Neoplasms, Advanced Metastatic Colorectal Cancer

In brief

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. In other types of cancers, it has been possible to improve treatment by studying the gene mutations (called biomarkers) in a patient's cancer and "matching" these to existing cancer therapies or study drugs which target that specific mutation. Colorectal cancers have not been routinely tested in this way. In this study, investigators will determine whether mutational testing can be successfully done on colorectal cancers and how often mutations are detected for which there are existing drugs (or drugs in development). The results will be used to determine if treating physicians use this information in planning subsequent treatment.

Key facts

Study ID

NCT01909362

Run by

US Oncology Research

People needed

52

Starts

2013-07-01

Expected to finish

2014-02-01

Last updated by the study team

2014-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 13 sites within US — Incl Greenville, SC and Tyler, TX, Texas, United States

Full record on ClinicalTrials.gov

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