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Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

NCT ID: NCT00133913

Last Updated: 2008-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Neoplasm Metastasis

Keywords

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metastatic colorectal cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy.

Phlebotomy

Intervention Type PROCEDURE

Peripheral blood draws for testing of circulating tumor cells

Interventions

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Phlebotomy

Peripheral blood draws for testing of circulating tumor cells

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunicon

INDUSTRY

Sponsor Role lead

Responsible Party

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Immunicon

Principal Investigators

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Steven Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Cohen SJ, Alpaugh RK, Gross S, O'Hara SM, Smirnov DA, Terstappen LW, Allard WJ, Bilbee M, Cheng JD, Hoffman JP, Lewis NL, Pellegrino A, Rogatko A, Sigurdson E, Wang H, Watson JC, Weiner LM, Meropol NJ. Isolation and characterization of circulating tumor cells in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Jul;6(2):125-32. doi: 10.3816/CCC.2006.n.029.

Reference Type BACKGROUND
PMID: 16945168 (View on PubMed)

Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25.

Reference Type DERIVED
PMID: 23014524 (View on PubMed)

Related Links

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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=25082

510(k) Premarket Notification

Other Identifiers

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IMMC-06

Identifier Type: -

Identifier Source: org_study_id