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Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00898781
Recruitment Status : Terminated (Due to poor accrual)
First Posted : May 12, 2009
Last Update Posted : July 19, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date July 19, 2011
Study Start Date November 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2011)
  • Frequency of circulating cancer cells (CTC) [ Time Frame: 1 day ]
  • Variability in number of CTCs between patients with the same tumor type [ Time Frame: 1 day ]
  • Correlation of the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers [ Time Frame: 1 day ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Frequency of circulating cancer cells (CTC)
  • Variability in number of CTCs between patients with the same tumor type
  • Correlation of the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer
Official Title Molecular Detection of Circulating Cancer Cells in Breast, Ovarian, Colon and Pancreatic Cancer
Brief Summary

RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.

PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

Detailed Description

OBJECTIVES:

  • To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
  • To assess the variability in number of CTCs between patients with the same tumor type.
  • To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.

OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

Registration - Inclusion Criteria

  • Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease or pre-operative clinically staged 3 ovarian cancer or locally advanced or metastatic pancreatic cancer.
  • Not received prior therapy for metastatic disease.

Registration - Exclusion Criteria:

-History of any prior cancer

Condition
  • Breast Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Metastatic Breast Cancer
  • Metastatic Ovarian Cancer
  • Metastatic Pancreatic Cancer
  • Metastatic Colon Cancer
  • Stage 3 Ovarian Cancer
  • Locally Advanced Pancreatic Cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: March 3, 2011)
80
Original Estimated Enrollment
 (submitted: May 9, 2009)
20
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No history of any prior cancer

PRIOR CONCURRENT THERAPY:

  • No prior therapy for metastatic disease
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898781
Other Study ID Numbers CDR0000582085
P30CA015083 ( U.S. NIH Grant/Contract )
MC0744 ( Other Identifier: Mayo Clinic Cancer Center )
07-006779 ( Other Identifier: Mayo Clinic IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Charles Erlichman, M.D., Mayo Clinic Cancer Center
Study Sponsor Mayo Clinic
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Charles Erlichman, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2011