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

NCT00898781 | Terminated DMC

• 4 other identifiers: CDR0000582085P30CA015083MC074407-006779
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Frequency of circulating cancer cells (CTC)

  1 day

• Variability in number of CTCs between patients with the same tumor type

  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

  1 day

Study Arms (6)

Metastatic Breast Cancer

Metastatic Ovarian Cancer

Metastatic Pancreatic Cancer

Metastatic Colon Cancer

Stage 3 Ovarian Cancer

Locally Advanced Pancreatic Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Breast Neoplasms, Male; Carcinoma, Ovarian Epithelial; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue 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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Charles Erlichman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

US (1)