Biomarker Analysis for Patients With Metastatic Colorectal Cancer (MCC)
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|ClinicalTrials.gov Identifier: NCT01909362|
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : February 26, 2014
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.
|Condition or disease|
|Colorectal Neoplasms Advanced Metastatic Colorectal Cancer|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Observational Model:||Case Control|
|Official Title:||Feasibility Study of Biomarker Analysis for Patients With Metastatic Colorectal Cancer|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Early recurrence (≤ 12 months)
Biospecimens from 25 patients who have had early recurrence (≤ 12 months) of their metastatic colorectal cancer
Late recurrence (> 12 months)
Biospecimens from 25 patients who have had late recurrence (> 12 months) of their metastatic colorectal cancer
- number of drug targetable genetic changes found in tumor tissue sample [ Time Frame: 6 months ]The frequencies and sites of 47 clinically relevant mutations or amplifications from biospecimens of early and/or late recurrence patients will be tabulated and summarized based on the evaluable population, respectively. The number of clinically actionable mutations with FDA-approved drugs will be compared to the number without and to those with associated clinical trials.
- number and cause of failed analyses after registration and tissue submission [ Time Frame: 6 months ]Samples submitted for analysis will be from archived FFPE tissue. Ability to perform the AmpliSeq testing may be limited based on the quality and quantity of the sample available. Reasons for testing failures may be due to an inability to extract sufficient quality and quantity of DNA, inability to create a sequencing library or inability for a sample to sequence. Should a testing failure occur, the reason for the testing failure will be recorded by the laboratory and reported back to the clinician. A patient will have the opportunity, in discussion with their study physician, dependent on space in the study and approval from the US Oncology Clinical Project Manager, be allowed to re-submit one additional sample for sequencing. If a sample from a patient is a testing failure after 2 testing attempts, the patient is considered a permanent testing failure and will not be offered an opportunity to submit any additional samples.
- number of physicians who took into consideration regimens that were suggested by the results of the sequencing analysis when deciding their patients' next line of therapies. [ Time Frame: 6 months ]
Biospecimen Retention: Samples With DNA
Tumor tissue (biopsy or surgery) 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909362
|United States, Texas|
|13 sites within US|
|incl Greenville, SC and Tyler, TX, Texas, United States|
|Principal Investigator:||Ki Y. Chung, M.D.||US Oncology Research, McKesson Specialty Health|
|Principal Investigator:||Donald A. Richards, M.D., Ph.D||US Oncology Research, McKesson Specialty Health|