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

NCT00899496 — Completed, 54 participants, Wake Forest University Health Sciences

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Pilot Study of Cancer Resistance in Humans

RegistryNCT00899496
StatusCompleted
Study typeObservational
Enrollment54 (Actual)
SponsorWake Forest University Health Sciences (Other); collaborators: National Cancer Institute (NCI)
ConditionsCancer
Interventionsimmunological diagnostic method, physiologic testing (Other)
Datesstart 2005-09-01, primary completion 2009-10-23, completion 2009-10-23, first posted 2009-05-12, last updated 2017-05-30
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cancer All trials of immunological diagnostic method All trials of physiologic testing

-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.

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+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.

+Arms and interventions

  • immunological diagnostic method (Other)
  • physiologic testing (Other)

+Outcome measures

Primary outcomes

  • Cell killing ability (positive or negative) [Day 180]
  • Percentage of cells killed [Day 180]

+Eligibility

Sex: All, ages: any to 120 Years, accepts healthy volunteers

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)

+Locations (1)

FacilityCityCountryStatus
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North CarolinaUnited States

+Investigators

+Funding

NIH grants: P30CA012197