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

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. Identifier: NCT00133913
Recruitment Status : Unknown
Verified March 2008 by Immunicon.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2005
Last Update Posted : March 19, 2008
Information provided by:

August 22, 2005
August 24, 2005
March 19, 2008
March 2004
January 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00133913 on 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.
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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
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 Identifier (NCT Number) in Medline.
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Senior Director, Clinical Development, Immunicon
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Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center
March 2008