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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00899496
First received: May 9, 2009
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cancer
Other: immunological diagnostic method
Other: physiologic testing

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study of Cancer Resistance in Humans

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Cell killing ability (positive or negative) [ Designated as safety issue: No ]
  • Percentage of cells killed [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2005
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.

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
    • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899496

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Zheng Cui, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00899496     History of Changes
Other Study ID Numbers: CCCWFU 95A05, P30CA012197, CCCWFU-99A05, CCCWFU-BG05-342
Study First Received: May 9, 2009
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
stage IV bladder cancer
stage IV colon cancer
stage IV non-small cell lung cancer
stage IV pancreatic cancer
stage IV rectal cancer
stage IV renal cell cancer
stage IV melanoma
stage III multiple myeloma
extensive stage small cell lung cancer
stage IV adult soft tissue sarcoma
stage III malignant testicular germ cell tumor
stage IV breast cancer
stage IV ovarian epithelial cancer
stage IV prostate cancer
stage IV endometrial carcinoma
unspecified adult solid tumor, protocol specific
metastatic osteosarcoma
stage IV uterine sarcoma
stage III ovarian epithelial cancer
ovarian sarcoma
stage IV adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage III adult Burkitt lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma

ClinicalTrials.gov processed this record on September 18, 2014