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Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00899496
First received: May 9, 2009
Last updated: May 25, 2017
Last verified: April 2017
May 9, 2009
May 25, 2017
September 2005
October 23, 2009   (Final data collection date for primary outcome measure)
  • Cell killing ability (positive or negative) [ Time Frame: Day 180 ]
  • Percentage of cells killed [ Time Frame: Day 180 ]
  • Cell killing ability (positive or negative)
  • Percentage of cells killed
Complete list of historical versions of study NCT00899496 on ClinicalTrials.gov Archive Site
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Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants
Pilot Study of Cancer Resistance in Humans

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.

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.

Observational
Observational Model: Other
Time Perspective: Prospective
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Non-Probability Sample
Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.
Cancer
  • Other: immunological diagnostic method
  • Other: physiologic testing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 23, 2009
October 23, 2009   (Final data collection date for primary outcome measure)

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
    • Stage IV renal cancer
    • Stage III or IV non-Hodgkin's lymphoma
    • Stage IV bladder cancer
    • Stage III multiple myeloma (Salmon-Durie staging)
    • Metastatic melanoma
    • Metastatic sarcoma
  • Healthy participant, meeting the following criteria:

    • No prior cancer
    • Over 50 years of age

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)
Sexes Eligible for Study: All
up to 120 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00899496
CCCWFU 95A05
P30CA012197 ( US NIH Grant/Contract Award Number )
CCCWFU-99A05
CCCWFU-BG05-342
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Zheng Cui, PhD Wake Forest University Health Sciences
Wake Forest University Health Sciences
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP