Thoracic CancersNCT00242723
Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining
An observational study of Thoracic Cancers and Malignant Pleural Mesotheliomas NOS, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 120 years
- Conditions the study is for
- Thoracic Cancers, Malignant Pleural Mesotheliomas NOS, Lung Cancer NOS
- How many people
- 1,559 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2005to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary clinical@@@
Who may be able to join
- 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,
Show all 11Show fewer
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients With Thoracic Malignancies
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.
Read more
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.
Read the detailed description
Background:
- Lung and esophageal cancers as well as malignant pleural mesotheliomas exhibit epigenetic perturbations that may impact the clinical course of these neoplasms.
- To date, epigenetic alterations in primary thoracic malignancies and neoplasms metastatic to the chest have not been evaluated in a systematic, longitudinal manner.
Objectives:
- To permit evaluation of patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for clinical research protocols.
- To use clinically obtained tumor and adjacent normal tissues as well as serum and urine samples from participants with primary or metastatic malignancies involving the lung, esophagus, pleura, and mediastinum to support preclinical research endeavors in the Thoracic Surgery Branch.
- To perform focused germline testing of genes modulating drug metabolism, possible future whole genome sequencing studies, possible ex vivo generation of autologous tumor cell lines and EBV-transformed B cell lines for research. Tumor tissue obtained during previous protocol participation and cryopreserved may undergo this process if the individual consents on this trial.
- To permit standard treatment for participants who are not eligible for investigational therapy on a current Thoracic Surgery protocol, but who present a novel and unique clinical training opportunity, or who manifest a clinical condition that requires immediate intervention to prevent compromise to the individual's well-being.
- To permit long term follow up of participants with thoracic malignancies including the collection of tissue and fluids to support preclinical research particularly to ascertain if gene expression and DNA methylation profiles coincide with response to therapy.
Eligibility:
- Individuals with potentially malignant or suspicious lesions or with biopsy proven, lung or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, thymoma/thymic neoplasms, or pulmonary metastases from cancers of nonthoracic origin.
- Individuals who 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 (biopsy or surgery).
- Age >= 2 years and older. 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.
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.
- Where appropriate, participants will receive clinically indicated standard staging, surgical intervention, and follow up care. After recovery from the clinically indicated biopsy or surgery participants will continue to be followed on this study, and blood and urine samples may be collected for research purposes; tissue from further clinically indicated procedures may be collected as well when appropriate.
- No investigational treatment will be administered on this protocol. In circumstances approved by the Section Chief, a participant may be deemed ineligible for investigational therapy, yet may undergo standard of care treatment at the NIH Clinical Center on this study.
- It is anticipated that up to 1,559 participants will be enrolled and followed 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, Thoracic Malignancies
- Keywords
- Biopsy, Staging Studies, Screening, potentially malignant or suspicious lesions, Cancer Primary Evaluation, Lung Cancer, Esophageal Cancer, Malignant Pleural Mesothelioma
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Cohort 1 | Participants with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: open-ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study start9 Nov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thoracic CancersStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,559 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David S Schrump, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242723
- Sponsor's protocol ID
- 060014
- Other IDs
- 06-C-0014
- Status last verified
- 7 Oct 2026
- First submitted
- 20 Oct 2005
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Schrump DS, Waheed I. Strategies to circumvent SV40 oncoprotein expression in malignant pleural mesotheliomas. Semin Cancer Biol. 2001 Feb;11(1):73-80. doi: 10.1006/scbi.2000.0348.
PubMed 11243901Schrump DS, Nguyen DM. Targeting the epigenome for the treatment and prevention of lung cancer. Semin Oncol. 2005 Oct;32(5):488-502. doi: 10.1053/j.seminoncol.2005.07.007.
PubMed 16210090Hong JA, Kang Y, Abdullaev Z, Flanagan PT, Pack SD, Fischette MR, Adnani MT, Loukinov DI, Vatolin S, Risinger JI, Custer M, Chen GA, Zhao M, Nguyen DM, Barrett JC, Lobanenkov VV, Schrump DS. Reciprocal binding of CTCF and BORIS to the NY-ESO-1 promoter coincides with derepression of this cancer-testis gene in lung cancer cells. Cancer Res. 2005 Sep 1;65(17):7763-74. doi: 10.1158/0008-5472.CAN-05-0823.
PubMed 16140944Wong-Rolle A, Dong Q, Zhu Y, Divakar P, Hor JL, Kedei N, Wong M, Tillo D, Conner EA, Rajan A, Schrump DS, Jin C, Germain RN, Zhao C. Spatial meta-transcriptomics reveal associations of intratumor bacteria burden with lung cancer cells showing a distinct oncogenic signature. J Immunother Cancer. 2022 Jul;10(7):e004698. doi: 10.1136/jitc-2022-004698.
PubMed 35793869
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Genetic and Epigenetic Alterations in Patients With Thoracic Malignancies
- ClinicalTrials.gov ID
- NCT00242723
- Acronym / sponsor ID
- 060014
- 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, Thoracic Malignancies
- Keywords
- Biopsy, Staging Studies, Screening, potentially malignant or suspicious lesions, Cancer Primary Evaluation, Lung Cancer, Esophageal Cancer, Malignant Pleural Mesothelioma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,559 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Nov 2005 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Lung and esophageal cancers as well as malignant pleural mesotheliomas exhibit epigenetic perturbations that may impact the clinical course of these neoplasms.
- To date, epigenetic alterations in primary thoracic malignancies and neoplasms metastatic to the chest have not been evaluated in a systematic, longitudinal manner.
Objectives:
- To permit evaluation of patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for clinical research protocols.
- To use clinically obtained tumor and adjacent normal tissues as well as serum and urine samples from participants with primary or metastatic malignancies involving the lung, esophagus, pleura, and mediastinum to support preclinical research endeavors in the Thoracic Surgery Branch.
- To perform focused germline testing of genes modulating drug metabolism, possible future whole genome sequencing studies, possible ex vivo generation of autologous tumor cell lines and EBV-transformed B cell lines for research. Tumor tissue obtained during previous protocol participation and cryopreserved may undergo this process if the individual consents on this trial.
- To permit standard treatment for participants who are not eligible for investigational therapy on a current Thoracic Surgery protocol, but who present a novel and unique clinical training opportunity, or who manifest a clinical condition that requires immediate intervention to prevent compromise to the individual's well-being.
- To permit long term follow up of participants with thoracic malignancies including the collection of tissue and fluids to support preclinical research particularly to ascertain if gene expression and DNA methylation profiles coincide with response to therapy.
Eligibility:
- Individuals with potentially malignant or suspicious lesions or with biopsy proven, lung or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, thymoma/thymic neoplasms, or pulmonary metastases from cancers of nonthoracic origin.
- Individuals who 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 (biopsy or surgery).
- Age >= 2 years and older. 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.
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.
- Where appropriate, participants will receive clinically indicated standard staging, surgical intervention, and follow up care. After recovery from the clinically indicated biopsy or surgery participants will continue to be followed on this study, and blood and urine samples may be collected for research purposes; tissue from further clinically indicated procedures may be collected as well when appropriate.
- No investigational treatment will be administered on this protocol. In circumstances approved by the Section Chief, a participant may be deemed ineligible for investigational therapy, yet may undergo standard of care treatment at the NIH Clinical Center on this study.
- It is anticipated that up to 1,559 participants will be enrolled and followed on this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Cohort 1 | – | –Participants with potentially malignant or suspicious lesions, or biopsy proven thoracic cancers or thoracic metastases from cancers of non-thoracic origin |
Who may qualify
- Ages
- 2 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary clinical@@@
Key inclusion criteria (11 listed)
- 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.
- -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,
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Obtain specimens for research from study participants
Time frame: open-ended
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 11243901Schrump DS, Waheed I. Strategies to circumvent SV40 oncoprotein expression in malignant pleural mesotheliomas. Semin Cancer Biol. 2001 Feb;11(1):73-80. doi: 10.1006/scbi.2000.0348.
- Background: PubMed 16210090Schrump DS, Nguyen DM. Targeting the epigenome for the treatment and prevention of lung cancer. Semin Oncol. 2005 Oct;32(5):488-502. doi: 10.1053/j.seminoncol.2005.07.007.
- Background: PubMed 16140944Hong JA, Kang Y, Abdullaev Z, Flanagan PT, Pack SD, Fischette MR, Adnani MT, Loukinov DI, Vatolin S, Risinger JI, Custer M, Chen GA, Zhao M, Nguyen DM, Barrett JC, Lobanenkov VV, Schrump DS. Reciprocal binding of CTCF and BORIS to the NY-ESO-1 promoter coincides with derepression of this cancer-testis gene in lung cancer cells. Cancer Res. 2005 Sep 1;65(17):7763-74. doi: 10.1158/0008-5472.CAN-05-0823.
- Derived from this study: PubMed 35793869Wong-Rolle A, Dong Q, Zhu Y, Divakar P, Hor JL, Kedei N, Wong M, Tillo D, Conner EA, Rajan A, Schrump DS, Jin C, Germain RN, Zhao C. Spatial meta-transcriptomics reveal associations of intratumor bacteria burden with lung cancer cells showing a distinct oncogenic signature. J Immunother Cancer. 2022 Jul;10(7):e004698. doi: 10.1136/jitc-2022-004698.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Thoracic Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David S Schrump, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Cancers and Malignant Pleural Mesotheliomas NOS, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca B Alexander ((240) 781-4037, rebecca.alexander@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242723, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.