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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00898781
• Other study ID #: CDR0000582085
• Secondary ID: P30CA015083MC074
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: July 18, 2011
• Start date: November 2007
• Est. completion date: April 2010

Study information

• Verified date: July 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of circulating cancer cells (CTC)		1 day	No
Primary	Variability in number of CTCs between patients with the same tumor type		1 day	No
Primary	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		1 day	No