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Sponsored by: |
Immunicon |
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Information provided by: | Immunicon |
ClinicalTrials.gov Identifier: | NCT00133913 |
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 | Intervention |
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Colorectal Cancer Neoplasm Metastasis |
Procedure: Phlebotomy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas |
Enrollment: | 486 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Cohort
Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy.
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Procedure: Phlebotomy
Peripheral blood draws for testing of circulating tumor cells
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Oncology patients from academic institutions and private practices
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Principal Investigator: | Steven Cohen, MD | Fox Chase Cancer Center |
Responsible Party: | Immunicon ( Senior Director, Clinical Development ) |
Study ID Numbers: | IMMC-06 |
Study First Received: | August 22, 2005 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00133913 |
Health Authority: | United States: Institutional Review Board |
metastatic colorectal cancer |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Neoplasm Metastasis Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Carcinoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |