NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining

RecruitingN/A

Sponsor: National Cancer Institute (NCI)

Conditions: Malignant Pleural Mesotheliomas NOS, Esophageal Cancers NOS, Lung Cancer NOS, Thoracic Cancers, Cancers of Non Thoracic Origin With Metastases to the Lungs or Pleura

Countries: United States

Background: * Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein. * Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in participants. * A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them. Objectives: * To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI clinical trials. * To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples to learn more about the cellular changes in blood and tissue in tumors of the lung, esophagus and pleura and surrounding structures in the chest. Eligibility: Participants 2 years of age and older with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung. Note: Patients \>= 2 years of age and under 18 years of age may only participate in research sample collection. Design: * Up to 1310 participants may be included in this study. * Participants undergo standard tests for evaluating the stage of their disease and for determining eligibility for an NCI investigational treatment study. * All participants undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water) to assess their tumor and collect a sample of normal tissue. Participants whose tumor is located on the outside portion of the lung may also undergo thoracoscopy to obtain a tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed through the nose or mouth into the lungs to examine the airways. Salt water is injected through the tube and then withdrawn to obtain cells for laboratory studies. For the thoracoscopy a small tube with a light is put through a small hole in the chest to obtain the tumor sample. Both procedures are usually done under general anesthesia. The tissue is examined to identify cell characteristics of people who respond to certain therapies and to identify markers on the surface of the tissue that may be useful in future research and treatment. * Blood and urine samples are collected from participants. * Participants who are eligible for a treatment study at NCI are offered participation in the study. * Participants for whom standard surgery, radiation or chemotherapy is more appropriate may receive treatment at NCI or with their own physician. * Participants who receive treatment at NCI return for follow-up examinations 4 weeks after discharge and then every 2 to 4 months depending on the nature of their cancer.

Eligibility overview

Sex: ALL

Age: 2 Years to 120 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

* INCLUSION CRITERIA:

Individuals with potentially malignant or suspicious lesions, or with biopsy proven lung cancers or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, thymoma/thymic carcinomas, or thoracic metastases from cancers of non-thoracic origin.

Individuals must have an ECOG performance score of 0-2.

Participants must:

-Have physical examination parameters within acceptable limits by standard of practice guidelines prior to clinically indicated surgical procedure (e.g., biopsy or surgery),

and

-Be aware of the nature of his/her illness,

and

-Must be willing to undergo clinically indicated standard intervention that may include endoscopic biopsies of tumor and adjacent normal tissues (i.e., other tissue necessary to obtain negative margins per standard of care surgical processes) as a part of their standard of care treatment plan.

Participants must agree to provide blood and urine samples to support ongoing laboratory research endeavors pertaining to the epigenetics of thoracic malignancies.

Individuals must be 2 years of age or older. Note: Individuals \>= 2 and \< 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure (e.g., biopsy or surgery), and the biospecimen sampling (e.g., blood, urine, \[clinically indicated\] resected tumor tissue) does not add risk to the clinically indicated procedures.

Ability of participant, their parents/guardians or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

None.

Locations (1)

Bethesda, Maryland, United States