Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01196130|
Recruitment Status : Active, not recruiting
First Posted : September 8, 2010
Last Update Posted : January 3, 2020
The goal of this clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs.
This is an investigational study. This study's biomarker testing is for research purposes only.
Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Behavioral: Cancer Symptom Questionnaire Other: Biomarker Testing|
|Study Type :||Observational|
|Actual Enrollment :||1275 participants|
|Official Title:||Assessment of Targeted Therapy Against Colorectal Cancer (ATTACC) Screening Protocol|
|Actual Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Leftover sample of tumor tissue from a previous procedure used for biomarker testing. Blood drawn for biomarker testing, to check for levels of cytokines, and to check the circulating tumor cells (CTCs). Cancer Symptom Questionnaire completion about cancer symptoms.
Behavioral: Cancer Symptom Questionnaire
5 minute questionnaire(s) completed at each study visit.
Other: Biomarker Testing
Blood draw at each study visit for biomarker and cytokine testing.
- Rate of Successful Biomarker Determination [ Time Frame: +/- 7 days ]Descriptive analysis performed to report the frequency of informative biomarkers for each of the companion allocation biomarkers as a proportion of patients enrolled onto the study. The primary analysis will be number of patients where informative biomarker results were determined for all tested biomarkers divided by the total number of patients enrolled on the study. Results reported separately for each of the individual biomarkers. Reasons for non-informative results reported descriptively.
Biospecimen Retention: Samples With DNA
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): NCT01196130
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Scott Kopetz, MD||M.D. Anderson Cancer Center|