An observational study in Thoracic Cancers, Malignant Pleural Mesotheliomas NOS and Lung Cancer NOS, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 2 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by National Cancer Institute (NCI) · Observational
Background:
Objectives:
Eligibility:
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).
Background:
Objectives:
Eligibility:
Design:
-This protocol is designed to:
--Facilitate screening of adult participants for investigational protocols in the Thoracic Surgery Branch, NCI. Adult participants will be screened to determine appropriate diagnostic and treatment interventions for their disease;
and
--As a tissue acquisition trial in which tissues will be obtained at the time of intervention from clinically indicated surgical procedures (i.e., standard of care biopsy or surgery) in order to enable evaluation of epigenetic events in primary and metastatic thoracic malignancies as an extension of ongoing laboratory research in the Thoracic Epigenetics Laboratory - including the establishment of tumor cell lines and EBVtransformed B cell lines to support immunologic evaluation of the participant's response to other clinical trials. Tissue, blood, and/or peritoneal/pleural effusion samples obtained during surgery/biopsy or clinic visits will be processed and either
stored for analysis or cultured for generation of tumor cell lines and EBV-transformed B cell lines for research.
339 studies on the registry are indexed under Mesothelioma, Malignant; 64 are open to participants now.
This study's planned enrollment of 1,559 is above the median of 150 across 40 observational studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Compared within Mesothelioma, Malignant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
primary clinical@@@
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals with potentially malignant or suspicious lesions, or with proven lung cancers or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, thymoma/thymic carcinomas, or thoracic from cancers of non-thoracic origin.
Individuals must have an 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 .
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 document.
EXCLUSION CRITERIA:
None.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin
Permit long-term follow-up of study participants for research to ascertain if gene expression and DNA methylation profiles coincide with response to therapy
Long-term follow-up visits at intervals based on participant's clinical status, to include history and medical exam, collection of research blood and urine; additional tissue from clinically indicated surgery/biopsy may be collected if available
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
Evaluation of adult patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for treatment/intervention research protocols
Time frame: open-ended
Obtain specimens for research from study participants
Specimens for research (tumor and adjacent normal tissues from clinically indicated biopsy or surgery, and blood, urine); research samples may be used for germline testing and ex vivo cell lines (autologous tumor cell lines and EBV-transformed B cell lines)
Time frame: open-ended
Plan to share: Yes — This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
Access criteria: Clinical data will be made available upon request and with the permission of the study PI. Genomic data are made available via dbGAP through requests to the data custodians.
Started Nov 2005 (actual).
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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