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

July 18, 2011 updated by: Mayo Clinic

Molecular Detection of Circulating Cancer Cells in Breast, Ovarian, Colon and Pancreatic Cancer

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.

Study Overview

Status

Terminated

Conditions

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

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Metastatic Breast Cancer
Metastatic Ovarian Cancer
Metastatic Pancreatic Cancer
Metastatic Colon Cancer
Stage 3 Ovarian Cancer
Locally Advanced Pancreatic Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of circulating cancer cells (CTC)
Time Frame: 1 day
1 day
Variability in number of CTCs between patients with the same tumor type
Time Frame: 1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Charles Erlichman, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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