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NCT00899496 Clinical Trial

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

Cancer Clinical Trial

Official title:
Pilot Study of Cancer Resistance in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00899496
Other study ID # CCCWFU 95A05
Secondary ID P30CA012197CCCWF
Status Completed
Phase N/A
First received May 9, 2009
Last updated May 25, 2017
Start date September 2005
Est. completion date October 23, 2009

Study information
Verified date April 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date October 23, 2009
Est. primary completion date October 23, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 120 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• immunological diagnostic method

• physiologic testing

Locations
Country Name City State
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cell killing ability (positive or negative) Day 180
Primary Percentage of cells killed Day 180
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