NCT00242723

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

Recruiting now Last updated 17 April 2026

What this trial tests

trial in Malignant Pleural Mesotheliomas NOS in 1,310 participants. Currently enrolling.

Timeline

9 November 2005

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,310
Start date	9 November 2005
Sites	1 location across United States

Conditions studied

• Malignant Pleural Mesotheliomas NOS — all drugs for Malignant Pleural Mesotheliomas NOS →
• Esophageal Cancers NOS — all drugs for Esophageal Cancers NOS →
• Lung Cancer NOS — all drugs for Lung Cancer NOS →
• Thoracic Cancers — all drugs for Thoracic Cancers →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 2 to 120, any sex, with Malignant Pleural Mesotheliomas NOS or Esophageal Cancers NOS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 patients.
* 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: Patients 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 patients may be included in this study.
* Patients undergo standard tests for evaluating the stage of their disease and for determining eligibility for an NCI investigational treatment study.
* All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water) to assess their tumor and collect a sample of normal tissue. Patients 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 patients.
* Patients who are eligible for a treatment study at NCI are offered participation in the study.
* Patients for whom standard surgery, radiation or chemotherapy is more appropriate may receive treatment at NCI or with their own physician.
* Patients 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spatial meta-transcriptomics reveal associations of intratumor bacteria burden with lung cancer cells showing a distinct oncogenic signature.
   Wong-Rolle A, Dong Q, Zhu Y, Divakar P, et al · · 2022 · cited 72× · PMID 35793869 · DOI 10.1136/jitc-2022-004698
2. The gut-tumor connection: the role of microbiota in cancer progression and treatment strategies.
   Wei Z, Gao G, He Q, Kwok LY, et al · · 2026 · cited 3× · PMID 40850681 · DOI 10.1016/j.jare.2025.08.038
3. DNA Methylation in Lung Cancer: Predictive Biomarkers for Effective Immunotherapy.
   Kumari K, Kumar V, Verma C, Hsu PC, et al · · 2025 · PMID 41497171 · DOI 10.2147/ijgm.s552594