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Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer (IMMC-06)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Immunicon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Immunicon
ClinicalTrials.gov Identifier:
NCT00133913
First received: August 22, 2005
Last updated: March 17, 2008
Last verified: March 2008
History of Changes

August 22, 2005
March 17, 2008
March 2004
January 2007   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00133913 on ClinicalTrials.gov Archive Site
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Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas

This study enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Oncology patients from academic institutions and private practices
  • Colorectal Cancer
  • Neoplasm Metastasis
Procedure: Phlebotomy
Peripheral blood draws for testing of circulating tumor cells
Cohort
Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy.
Intervention: Procedure: Phlebotomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
486
January 2009
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Measurable metastatic carcinoma of the colon or rectum.
  • 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor [EGFR] targeted therapy)
  • Chest/abdomen/pelvis scans every 6-12 weeks
  • ECOG 0-2
  • Hemoglobin (Hgb) > or = 8g/dl within 7 days prior to enrollment
  • Age > or = to 18 years of age

Exclusion Criteria:

  • Cumulative weekly blood draws exceeding 150mL/week
  • Brain metastasis
  • Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer
  • Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00133913
IMMC-06
No
Senior Director, Clinical Development, Immunicon
Immunicon
Not Provided
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center
Immunicon
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP