Evaluation of cell changes in blood and tissue in lung and esophageal cancers
Prospective Evaluation of Genetic and Epigenetic Alterations in Patients With Thoracic Malignancies
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 |
|---|---|
| Enrollment | 1559 (estimated) |
| Ages | 2 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00242723 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with non-malignant conditions or those who do not have the specified cancer types may not benefit from this study.
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 performed: Other studies have shown success in evaluating epigenetic changes in cancers, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Patients 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. Patients must have an ECOG performance score of 0-2. Patients must be 2 years of age or older. Note: Patients \>= 2 and \< 18 years of age may participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures. Patients must be aware of the nature of his/her illness. The patient must be willing to undergo standard intervention that may include endoscopic biopsies of tumor and adjacent normal tissues, and to provide blood and urine samples to support ongoing laboratory research endeavors pertaining to the epigenetics of thoracic malignancies. Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: None.
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.