Colorectal Cancer Umbrella Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01196130
First received: September 3, 2010
Last updated: May 21, 2014
Last verified: May 2014
  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 ] [ Designated as safety issue: No ]
    Assessments at the time of each restaging study (+/- 7 days)


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: 880
Study Start Date: August 2010
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196130

Contacts
Contact: Scott Kopetz, MD 713-792-2828

Locations
United States, Texas
UT 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
Investigators
Principal Investigator: Scott Kopetz, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01196130     History of Changes
Other Study ID Numbers: 2009-0091
Study First Received: September 3, 2010
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014