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Completed

NCT Number: NCT00899496

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.

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Key information

Conditions

Cancer Adenocarcinoma Adnexal Diseases Blood Protein Disorders Breast Diseases Breast Neoplasms Bronchial Neoplasms Burkitt Lymphoma Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Cardiovascular Diseases Chronic Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Epstein-Barr Virus Infections Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Intraocular Lymphoma Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Diseases Lung Neoplasms Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Multiple Myeloma Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Osteosarcoma Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Sezary Syndrome Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Tumor Virus Infections Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

immunological diagnostic method

Other

Physiologic Testing

Other

Primary outcomes

  1. Cell killing ability (positive or negative)

    Time frame: Day 180

  2. Percentage of cells killed

    Time frame: Day 180

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Study of Cancer Resistance in Humans

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 12, 2009
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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