Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 1275 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Biomarker Assessment
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.




Primary Outcome Measures :
  1. 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
Blood (16 mL) collected and archived tumor samples (primary tumor or metastatic site) from prior surgeries or biopsies.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously treated with systemic chemotherapy for metastatic colorectal cancer.
Criteria

Inclusion Criteria:

  1. The patient has a histologically or cytologically confirmed colorectal adenocarcinoma with metastatic or unresectable, locally advanced disease documented on diagnostic imaging studies.
  2. The patient must have been previously treated with systemic chemotherapy for metastatic or unresectable, locally advanced colorectal cancer, with no limit on the number of prior regimens. Patients who develop recurrent or metastatic disease on or within 6 months of adjuvant therapy are eligible.
  3. Age >/=18 years to provide a uniform oncologic phenotype of adult-onset colorectal cancer.
  4. ECOG performance status 0-2.
  5. The patient has signed informed consent.

Exclusion Criteria:

1) Inability to comply with study and/or follow-up procedures.


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Scott Kopetz, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01196130    
Other Study ID Numbers: 2009-0091
R01CA172670 ( U.S. NIH Grant/Contract )
RP110584 ( Other Grant/Funding Number: CPRIT )
NCI-2017-00505 ( Registry Identifier: NCI CTRP )
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Metastatic colorectal cancer
CRC
Colorectal adenocarcinoma
Biomarker determination
Tumor tissue
Treatment protocols
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases