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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Cancer Neoplasm Metastasis Procedure: Phlebotomy

Study Design

Study Type : Observational
Actual Enrollment : 486 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas
Study Start Date : March 2004
Primary Completion Date : January 2007
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Cohort
Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy.
Procedure: Phlebotomy
Peripheral blood draws for testing of circulating tumor cells


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Oncology patients from academic institutions and private practices
Criteria

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
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): NCT00133913


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Immunicon
Investigators
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senior Director, Clinical Development, Immunicon
ClinicalTrials.gov Identifier: NCT00133913     History of Changes
Other Study ID Numbers: IMMC-06
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: March 19, 2008
Last Verified: March 2008

Keywords provided by Immunicon:
metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes