Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining
Recruiting
Observational Study
Thoracic CancersMalignant Pleural Mesotheliomas NOSLung Cancer NOSEsophageal Cancers NOSCancers of Non Thoracic Origin With Metastases to the Lungs or PleuraThoracic Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 120
Sex
Any
Study type
Observational
Participants needed
1,559 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 associat…
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.
Trial Locations
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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.
…
* 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.
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