Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer, Cancer, Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | Any - 100 |
| Updated: | 3/1/2019 |
| Start Date: | October 18, 2005 |
| Contact: | Tricia Kunst, R.N. |
| Email: | kunstt@mail.nih.gov |
| Phone: | (240) 760-6234 |
Prospective Evaluation of 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 patients.
- A better understanding of these diseases and the genetic changes associated with them
may be helpful in developing new treatments for them.
Objectives:
- To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI
clinical trials.
- To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples
to learn more about the cellular changes in blood and tissue in tumors of the lung,
esophagus and pleura and surrounding structures in the chest.
Eligibility: Patients 18 years of age and older with cancer of the lung, esophagus, pleura,
mediastinum or chest wall, or cancers of other origin that have invaded the lung.
Design:
- Up to 800 patients may be included in this study.
- Patients undergo standard tests for evaluating the stage of their disease and for
determining eligibility for an NCI investigational treatment study.
- All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water)
to assess their tumor and collect a sample of normal tissue. Patients whose tumor is
located on the outside portion of the lung may also undergo thoracoscopy to obtain a
tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed
through the nose or mouth into the lungs to examine the airways. Salt water is injected
through the tube and then withdrawn to obtain cells for laboratory studies. For the
thoracoscopy a small tube with a light is put through a small hole in the chest to
obtain the tumor sample. Both procedures are usually done under general anesthesia. The
tissue is examined to identify cell characteristics of people who respond to certain
therapies and to identify markers on the surface of the tissue that may be useful in
future research and treatment.
- Blood and urine samples are collected from patients.
- Patients who are eligible for a treatment study at NCI are offered participation in the
study.
- Patients for whom standard surgery, radiation or chemotherapy is more appropriate may
receive treatment at NCI or with their own physician.
- Patients who receive treatment at NCI return for follow-up examinations 4 weeks after
discharge and then every 2 to 4 months depending on the nature of their cancer.
- 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 patients.
- A better understanding of these diseases and the genetic changes associated with them
may be helpful in developing new treatments for them.
Objectives:
- To evaluate people with cancer of the lung, pleura or esophagus for participation in NCI
clinical trials.
- To obtain biopsies (small pieces of tissue) from tumor, normal tissue and blood samples
to learn more about the cellular changes in blood and tissue in tumors of the lung,
esophagus and pleura and surrounding structures in the chest.
Eligibility: Patients 18 years of age and older with cancer of the lung, esophagus, pleura,
mediastinum or chest wall, or cancers of other origin that have invaded the lung.
Design:
- Up to 800 patients may be included in this study.
- Patients undergo standard tests for evaluating the stage of their disease and for
determining eligibility for an NCI investigational treatment study.
- All patients undergo bronchoscopy and bronchoalveolar lavage ("washing" with salt water)
to assess their tumor and collect a sample of normal tissue. Patients whose tumor is
located on the outside portion of the lung may also undergo thoracoscopy to obtain a
tumor sample. For bronchoscopy and bronchoalveolar lavage a tube with a light is passed
through the nose or mouth into the lungs to examine the airways. Salt water is injected
through the tube and then withdrawn to obtain cells for laboratory studies. For the
thoracoscopy a small tube with a light is put through a small hole in the chest to
obtain the tumor sample. Both procedures are usually done under general anesthesia. The
tissue is examined to identify cell characteristics of people who respond to certain
therapies and to identify markers on the surface of the tissue that may be useful in
future research and treatment.
- Blood and urine samples are collected from patients.
- Patients who are eligible for a treatment study at NCI are offered participation in the
study.
- Patients for whom standard surgery, radiation or chemotherapy is more appropriate may
receive treatment at NCI or with their own physician.
- Patients who receive treatment at NCI return for follow-up examinations 4 weeks after
discharge and then every 2 to 4 months depending on the nature of their cancer.
Background:
-Lung and esophageal cancers as well as malignant pleural mesotheliomas exhibit profound
alterations in chromatin structure, which 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 manner.
Objectives:
- To permit evaluation of patients referred to the Thoracic Surgery Section, of the
Thoracic and GI Oncology Branch, NCI in order to identify individuals who will be
suitable candidates for clinical research protocols.
- To obtain biopsies during staging studies of tumor and adjacent normal tissues as well
as serum and urine samples from patients with primary or metastatic malignancies
involving the lung, esophagus, pleura, and mediastinum to support preclinical research
endeavors in the Thoracic Surgery Section.
- To obtain blood, buccal mucosa, tumor tissue or malignant peritoneal/pleural effusions
from patients with lung, esophageal, mediastinal, or chest wall malignancies for focused
germline testing of genes modulating drug metabolism, possible future whole genome
sequencing studies, possible ex vivo generation of autologous tumor cell lines and
EBVtransformed B cell lines for research. Tumor tissue obtained during previous protocol
participation and cryopreserved may undergo this process if the patient consents on this
trial.
- To permit standard treatment for patients 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 patient's well-being.
- To permit long term follow up of patients 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:
- 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 neoplasms, or pulmonary metastases from cancers of
non-thoracic origin.
- Patients who have an ECOG performance score of 0-2.
- Patients under 18 years of age may participate 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 have coagulation parameters within acceptable limits by standard of
practice guidelines prior to biopsy
Design:
- This protocol is designed to:
- facilitate screening of patients for investigational protocols in the Thoracic
Surgery Section, of the proposed Thoracic and GI Oncology Branch, NCI, and in doing
so, obtain tissue samples to enable evaluation of epigenetic events in primary and
metastatic thoracic malignancies, as an extension of ongoing laboratory research in
the Thoracic Oncology laboratory.
- allow for the establishment of tumor cell lines and EBV-transformed B cell lines to
support immunologic evaluation of the patient s response to other clinical trials.
- Patients will be screened to determine appropriate diagnostic and treatment
interventions. Where appropriate, patients will receive staging and surgical
intervention and necessary follow up care. Tissue, blood, and/or peritoneal/pleural
effusion samples obtained during surgery/biopsy or clinic visit will be processed and
either stored for analysis or cultured for generation of tumor cell lines and
EBV-transformed B cell lines for research. After recovery from biopsy or surgery
patients will continue to be followed, blood and urine samples will be collected as well
as tissue when appropriate.
- No investigational treatment will be administered on this protocol. In circumstances
approved by the Section Chief, a patient may be deemed ineligible for investigational
therapy, yet may present a unique clinical training experience for Thoracic Surgery
Section physicians and clinical associates, and undergo standard treatment.
- It is anticipated that the protocol will enroll ~ 75 - 80 patients per year over 10
years for a maximum of 800 patients.
-Lung and esophageal cancers as well as malignant pleural mesotheliomas exhibit profound
alterations in chromatin structure, which 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 manner.
Objectives:
- To permit evaluation of patients referred to the Thoracic Surgery Section, of the
Thoracic and GI Oncology Branch, NCI in order to identify individuals who will be
suitable candidates for clinical research protocols.
- To obtain biopsies during staging studies of tumor and adjacent normal tissues as well
as serum and urine samples from patients with primary or metastatic malignancies
involving the lung, esophagus, pleura, and mediastinum to support preclinical research
endeavors in the Thoracic Surgery Section.
- To obtain blood, buccal mucosa, tumor tissue or malignant peritoneal/pleural effusions
from patients with lung, esophageal, mediastinal, or chest wall malignancies for focused
germline testing of genes modulating drug metabolism, possible future whole genome
sequencing studies, possible ex vivo generation of autologous tumor cell lines and
EBVtransformed B cell lines for research. Tumor tissue obtained during previous protocol
participation and cryopreserved may undergo this process if the patient consents on this
trial.
- To permit standard treatment for patients 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 patient's well-being.
- To permit long term follow up of patients 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:
- 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 neoplasms, or pulmonary metastases from cancers of
non-thoracic origin.
- Patients who have an ECOG performance score of 0-2.
- Patients under 18 years of age may participate 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 have coagulation parameters within acceptable limits by standard of
practice guidelines prior to biopsy
Design:
- This protocol is designed to:
- facilitate screening of patients for investigational protocols in the Thoracic
Surgery Section, of the proposed Thoracic and GI Oncology Branch, NCI, and in doing
so, obtain tissue samples to enable evaluation of epigenetic events in primary and
metastatic thoracic malignancies, as an extension of ongoing laboratory research in
the Thoracic Oncology laboratory.
- allow for the establishment of tumor cell lines and EBV-transformed B cell lines to
support immunologic evaluation of the patient s response to other clinical trials.
- Patients will be screened to determine appropriate diagnostic and treatment
interventions. Where appropriate, patients will receive staging and surgical
intervention and necessary follow up care. Tissue, blood, and/or peritoneal/pleural
effusion samples obtained during surgery/biopsy or clinic visit will be processed and
either stored for analysis or cultured for generation of tumor cell lines and
EBV-transformed B cell lines for research. After recovery from biopsy or surgery
patients will continue to be followed, blood and urine samples will be collected as well
as tissue when appropriate.
- No investigational treatment will be administered on this protocol. In circumstances
approved by the Section Chief, a patient may be deemed ineligible for investigational
therapy, yet may present a unique clinical training experience for Thoracic Surgery
Section physicians and clinical associates, and undergo standard treatment.
- It is anticipated that the protocol will enroll ~ 75 - 80 patients per year over 10
years for a maximum of 800 patients.
- 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 18 years of age or older. Patients under 18 years of age may participate
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 neoplastic nature of his/her illness. The patient must be
willing to undergo endoscopic biopsies of tumor and adjacent normal tissues, and provide
blood (30cc) and urine (100cc) samples to support ongoing laboratory research endeavors
pertaining to the epigenetics of thoracic malignancies.
Ability of subject or legally authorized representative (LAR) to understand and the
willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: (888) NCI-1937
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