Laboratory Assay In Determining Cancer Resistance In Patients With Metastatic Cancer And In Healthy Participants

Study Overview

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

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.

Cancer

OTHER: immunological diagnostic method
OTHER: physiologic testing

CCCWFU 95A05
P30CA012197 (U.S. NIH Grant/Contract)
CCCWFU-99A05
CCCWFU-BG05-342

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-05-25
First Submitted that Met QC Criteria 2009-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-05-30
First Posted (ACTUAL) 2009-05-12	Results First Posted N/A	Last Verified 2017-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Cell killing ability (positive or negative)		Day 180
Percentage of cells killed		Day 180

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:
1

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Zheng Cui, PhD, Wake Forest University Health Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record