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

This study has been terminated.
(Due to poor accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898781
First Posted: May 12, 2009
Last Update Posted: July 19, 2011
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
  Purpose

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.


Condition
Breast Cancer Colorectal Cancer Ovarian Cancer Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Detection of Circulating Cancer Cells in Breast, Ovarian, Colon and Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: November 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Metastatic Breast Cancer
Metastatic Ovarian Cancer
Metastatic Pancreatic Cancer
Metastatic Colon Cancer
Stage 3 Ovarian Cancer
Locally Advanced 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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  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): NCT00898781


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Charles Erlichman, MD Mayo Clinic
  More Information

Responsible Party: Charles Erlichman, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00898781     History of Changes
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 )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by Mayo Clinic:
male breast cancer
stage IV breast cancer
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
stage IV pancreatic cancer
stage IV colon cancer
ovarian sarcoma

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases