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:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00898781
First received: May 9, 2009
Last updated: July 18, 2011
Last verified: July 2011
  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 ] [ Designated as safety issue: No ]
  • Variability in number of CTCs between patients with the same tumor type [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898781

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Charles Erlichman, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Charles Erlichman, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00898781     History of Changes
Other Study ID Numbers: CDR0000582085, P30CA015083, MC0744, 07-006779
Study First Received: May 9, 2009
Last Updated: July 18, 2011
Health Authority: United States: Federal Government

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
Ovarian 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
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Pancreatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014