Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Официальное название

Molecular Predictors of Lung Cancer Behavior

Обзор

RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Подробное описание

OBJECTIVES:

* To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions. * To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.

OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.

Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Вмешательства

• Генная терапия comparative genomic hybridization
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Генная терапия gene expression microarray analysis
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Генная терапия proteomic profiling analysis
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Другое biologic sample preservation procedure
  Collection of sputum, blood, urine, and a small amount of lung tissue.
• Процедура nasal brushing
  Using a brush, superficial cells are removed from the nose.
• Процедура Blood draw
  Venous blood will be collected
• Процедура Urine collection
  Subjects will be asked to provide a urine specimen.
• Процедура sputum sample
  Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up.
• Процедура fluorescence bronchoscopy with airway biopsy
  A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway.
• Процедура fine needle aspiration of the lung
  A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it.

Первичные конечные точки

• To quantitate the molecular changes during lung cancer development [Срок оценки: After collection of designated samples]

Вторичные конечные точки (1)

• Develop a method to diagnose and stage pre-invasive and invasive lesions [Срок оценки: After collection of designated samples]

Критерии участия

Критерии включения

-All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.

Критерии исключения

• Inability to provide informed consent
• Minors
• Pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Vanderbilt-Ingram Cancer Center — Nashville
• Veterans Affairs Medical Center - Nashville — Nashville

Идентификаторы

NCT: NCT00898313 · VICC THO 0398 · P30CA068485

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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