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Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT00897754
First received: May 9, 2009
Last updated: May 17, 2017
Last verified: May 2017
  Purpose

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.


Condition Intervention
Colorectal Cancer Genetic: gene expression analysis Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunoenzyme technique Other: immunohistochemistry staining method Other: immunologic technique

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Alternative Splice Forms of VEGF in Colorectal Cancer - Possible Value in Anti-VEGF Therapy

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Primary Outcome Measures:
  • Mean scores for VEGFb and pan-VEGF gene expression by IHC [ Time Frame: 1 month ]
  • Gene expression as measured by tissue microarrays [ Time Frame: 1 month ]
  • Splice form expression as measured by reverse transcriptase-PCR [ Time Frame: 1 month ]
  • VEGF165b protein expression as measured by ELISA [ Time Frame: 1 month ]

Enrollment: 200
Actual Study Start Date: July 24, 2007
Study Completion Date: February 1, 2009
Primary Completion Date: February 1, 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy.

OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients participating in E3200
Criteria

DISEASE CHARACTERISTICS:

  • Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum

    • Receiving bevacizumab on clinical trial E-3200

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  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: NCT00897754

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: David Bates, PhD Bristol Heart Institute at University of Bristol
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00897754     History of Changes
Other Study ID Numbers: CDR0000560986
ECOG-E3200T2
Study First Received: May 9, 2009
Last Updated: May 17, 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
stage III colon cancer
stage IV colon cancer

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 August 17, 2017