Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT00242723

Conditions

Thoracic Cancers

Malignant Pleural Mesotheliomas NOS

Lung Cancer NOS

Esophageal Cancers NOS

Cancers of Non Thoracic Origin With Metastases to the Lungs or Pleura

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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 medically evaluate individuals with potential (medically suspicious) or proven cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, and then, to determine eligibility for NCI investigational treatment studies for participants >18 years of age (adult participants only).
  • To use clinically obtained biopsies (small pieces of tissue) of tumor and adjacent normal tissue from clinically indicated procedures (standard of care biopsy or surgery), as well as blood and urine samples, from participants with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, for research into immune and cellular changes of these cancers. Study research includes genetic testing and the growth of laboratory cell lines from participant samples, to examine how genes change drug metabolism.
  • To permit long-term follow-up of participants with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, for natural history research on genetics and if the gene expression coincides with clinical response to patient anti-cancer therapies (treatment received at NCI or from participant's own physicians).

Eligibility:

  • Individuals 2 years of age and older with potential (medically suspicious) or proven cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung. Note: Individuals >= 2 years of age and under 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood or urine does NOT add risk to the clinically indicated procedures.
  • Participants must have physical examination parameters within acceptable limits by standard of practice guidelines prior to clinically indicated surgical procedure (standard of care biopsy or surgery).

Design:

  • All participants will undergo standard tests to evaluate the stage of their disease, and then, eligibility determination for NCI investigational treatment studies will be made for participants >18 years of age (adult participants only).

  • Participants >18 years of age (adult participants only) who are determined to be eligible for a treatment study at NCI are offered participation in that study. No investigational treatment is administered on this protocol.
  • Participants >= 2 years of age (all participants) may receive standard of care treatment at NCI or with their own physician if it is determined that standard of care surgery, radiation, or chemotherapy is more clinically appropriate for that participant's disease status.
  • Participants who receive standard of care biopsy or surgery (clinically indicated standard staging, surgical intervention, and follow up care) at the NIH Clinical Center are expected to return for a clinical examination visit post-procedure (for instance, 4 weeks after discharge from surgery). After recovery, participants will return to the NIH Clinical Center for study follow-up visits at intervals based on their clinical status (such as every 3 to 36 months) until the end of study participation.
  • Blood and urine samples are collected from all participants for study research at baseline and study visits until the end of study participation. If participants have additional clinically indicated biopsies or surgeries, resected tissue may be collected for study research (as logistically appropriate).
  • It is expected that up to 1,559 participants will be enrolled and followed long-term on this study.

Conditions

Thoracic Cancers

Malignant Pleural Mesotheliomas NOS

Lung Cancer NOS

Esophageal Cancers NOS

Cancers of Non Thoracic Origin With Metastases to the Lungs or Pleura

Study ID

NCT00242723

Start date

Nov 9, 2005

Status verified date

Aug 19, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

1559 participants

Anticipated

Interventions and Outcome Measures

Arms

1/Cohort 1

Participants with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin

Primary outcome measure

  • Permit long-term follow-up of study participants for research to ascertain if gene expression and DNA methylation profiles coincide with response to therapy [ Time Frame: open-ended ]
  • Permit evaluation of adult patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for treatment/intervention protocols [ Time Frame: open-ended ]
  • Obtain specimens for research from study participants [ Time Frame: open-ended ]

Central Contacts and Locations

Central contacts

Rebecca B Alexander

(240) 781-4037rebecca.alexander@nih.gov

David S Schrump, M.D.

(240) 760-6239david_schrump@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 8, 2026

Last verified

Aug 19, 2026

Keywords

  • Biopsy
  • Staging Studies
  • Screening
  • potentially malignant or suspicious lesions
  • Cancer Primary Evaluation
  • Lung Cancer
  • Esophageal Cancer
  • Malignant Pleural Mesothelioma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-08.