Biomarker Analysis for Patients With Metastatic Colorectal Cancer (MCC)

NCT01909362 | Completed

• 1 other identifier: 12246
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Colorectal Neoplasms; Advanced Metastatic Colorectal Cancer

Keywords

advanced metastatic colorectal cancer; mCRC; Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Genetic mutation testing; Tumor tissue sampling

Outcome Measures

Primary Outcomes (1)

• number of drug targetable genetic changes found in tumor tissue sample

  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.

  6 months

Secondary Outcomes (2)

• number and cause of failed analyses after registration and tissue submission

  6 months

• 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.

  6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with metastatic colorectal cancer seen within the US Oncology network

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

Sponsors & Collaborators

• US Oncology Research: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

13 sites within US

Incl Greenville, SC and Tyler, TX, Texas, United States

Location

Related Publications (1)

• de Gramont A, Hubbard J, Shi Q, O'Connell MJ, Buyse M, Benedetti J, Bot B, O'Callaghan C, Yothers G, Goldberg RM, Blanke CD, Benson A, Deng Q, Alberts SR, Andre T, Wolmark N, Grothey A, Sargent D. Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set. J Clin Oncol. 2010 Jan 20;28(3):460-5. doi: 10.1200/JCO.2009.23.1407. Epub 2009 Dec 14.

  PMID: 20008641 BACKGROUND

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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 26, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

US (1)