Clinical trial NCT00898781: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Colorectal Cancer
Ovarian Cancer
Pancreatic Cancer
Keywords: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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

Primary outcomes:
measure: Frequency of circulating cancer cells (CTC)
timeFrame: 1 day
measure: Variability in number of CTCs between patients with the same tumor type
timeFrame: 1 day
measure: 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
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Erlichman, MD
role: PRINCIPAL_INVESTIGATOR
References: