Evaluation of cell changes in blood and tissue in lung and esophageal cancers
Official title: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients With Thoracic Malignancies
Run by National Institutes of Health Clinical Center (CC) · NCT00242723 · Data updated 2026-11-12
This study is testing how cell changes in blood and tissue relate to lung and esophageal cancers to help improve understanding and treatment for patients aged 2 and older with these cancers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 120 Years |
| Sex | All |
| Enrollment | 1559 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 9, 2005 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT00242723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 2 years and older with lung, pleura, or esophageal cancers, or those with cancers that have metastasized to the lungs.
✕Probably not a fit
Patients with non-malignant conditions or those who do not have the specified cancer types may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate patients with lung, pleura, or esophageal cancers to understand the cellular changes associated with these malignancies. It involves obtaining biopsies from tumor and normal tissues, as well as blood and urine samples, to support research on epigenetic alterations in these cancers. The study seeks to identify suitable candidates for clinical trials and enhance the understanding of disease progression and treatment responses. Patients aged 2 years and older with specific cancer types are eligible for participation.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with lung and esophageal cancers.
How similar studies have gone: Other studies have shown success in evaluating epigenetic changes in cancers, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: David S Schrump, M.D. — National Cancer Institute (NCI)
- Study coordinator: Rebecca B Alexander
- Email: rebecca.alexander@nih.gov
- Phone: (240) 781-4037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.