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Clinical Trials/NCT00899496
NCT00899496
Completed
Not Applicable

Pilot Study of Cancer Resistance in Humans

Wake Forest University Health Sciences1 site in 1 country54 target enrollmentSeptember 2005
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
54
Locations
1
Primary Endpoint
Cell killing ability (positive or negative)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer.

PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.

Detailed Description

OBJECTIVES: * Optimize and standardize the in vitro cell kill assay using human white blood cells and human cancer cell lines from patients with metastatic cancer and from healthy participants. * Determine the results of the in vitro cell kill assay in patients with metastatic cancer and in healthy participants with no history of cancer. OUTLINE: This is a pilot study. Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is collected from archived samples. White blood cells are obtained from tissue and blood samples and are assessed by the in vitro cell kill assay. PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for this study.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
October 23, 2009
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Meets 1 of the following criteria:
  • Diagnosis of metastatic cancer including, but not limited to, any of the following:
  • Stage IV non-small cell lung cancer
  • Extensive-stage small cell lung cancer
  • Metastatic testicular cancer
  • Stage IV breast carcinoma
  • Stage III or IV ovarian carcinoma
  • Stage IV endometrial carcinoma
  • Stage IV prostate carcinoma
  • Stage IV colorectal or pancreatic cancer

Exclusion Criteria

  • Serious medical or psychiatric condition that would preclude study compliance
  • Chemotherapy or radiotherapy within the past 3 months (patient)
  • Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)

Outcomes

Primary Outcomes

Cell killing ability (positive or negative)

Time Frame: Day 180

Percentage of cells killed

Time Frame: Day 180

Study Sites (1)

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