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

NCT ID: NCT00899496

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-10-23

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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immunological diagnostic method

Intervention Type OTHER

physiologic testing

Intervention Type OTHER

Eligibility Criteria

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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)
Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zheng Cui, PhD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

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Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCCWFU-99A05

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-BG05-342

Identifier Type: -

Identifier Source: secondary_id

CCCWFU 95A05

Identifier Type: -

Identifier Source: org_study_id

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