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Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol

This study is currently recruiting participants.
Verified October 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01196130
First Posted: September 8, 2010
Last Update Posted: October 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Colorectal Cancer Behavioral: Cancer Symptom Questionnaire Other: Biomarker Testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Targeted Therapy Against Colorectal Cancer (ATTACC) Screening Protocol

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 1200
Actual Study Start Date: August 2010
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
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


Contacts
Contact: Gastrointestinal Medical Oncology 713-792-2828

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Scott Kopetz, MD    713-792-2828      
Principal Investigator: Scott Kopetz, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Scott Kopetz, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01196130     History of Changes
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 Submitted: September 3, 2010
First Posted: September 8, 2010
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Metastatic colorectal cancer
CRC
Colorectal adenocarcinoma
Biomarker determination
Tumor tissue
Treatment protocols

Additional relevant 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