NCT00133913

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 19, 2008

Status Verified

March 1, 2008

Enrollment Period

2.8 years

First QC Date

August 22, 2005

Last Update Submit

March 17, 2008

Conditions

Colorectal CancerNeoplasm Metastasis

Keywords

metastatic colorectal cancer

Study Arms (1)

Cohort

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

Procedure: Phlebotomy

Interventions

PhlebotomyPROCEDURE

Peripheral blood draws for testing of circulating tumor cells

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Oncology patients from academic institutions and private practices

You may qualify if:

  • Measurable metastatic carcinoma of the colon or rectum.
  • st 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (2)

  • 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.

    PMID: 16945168BACKGROUND

  • 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.

    PMID: 23014524DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Steven Cohen, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2009

Last Updated

March 19, 2008

Record last verified: 2008-03

Locations

US(1)