Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242723
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2005-10-20
Brief Title:
Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung Esophagus and Lung Lining
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Evaluation of Genetic and Epigenetic Alterations in Patients With Thoracic Malignancies
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 2 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 Note Patients 2 years of age and under 18 years of age may only participate in research sample collection
Design
Up to 1100 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 2 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 Note Patients 2 years of age and under 18 years of age may only participate in research sample collection
Design
Up to 1100 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
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 obtain 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 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 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 patients 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 or esophageal cancers malignant pleural mesotheliomas mediastinal or chest wall neoplasms thymomathymic neoplasms or pulmonary metastases from cancers of non-thoracic origin
Patients who have an ECOG performance score of 0-2
Age 2 years and older Note Patients 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 patients for investigational protocols in the Thoracic Surgery Branch NCI and to 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 Epigenetics 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 standard staging surgical intervention and follow up care Tissue blood andor peritonealpleural effusion samples obtained during surgerybiopsy 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 After recovery from biopsy or surgery patients will continue to be followed blood and urine samples may 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 undergo standard of care treatment at the NIH Clinical Center on this study
It is anticipated that the protocol will enroll a maximum of 1310 patients
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 obtain 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 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 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 patients 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 or esophageal cancers malignant pleural mesotheliomas mediastinal or chest wall neoplasms thymomathymic neoplasms or pulmonary metastases from cancers of non-thoracic origin
Patients who have an ECOG performance score of 0-2
Age 2 years and older Note Patients 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 patients for investigational protocols in the Thoracic Surgery Branch NCI and to 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 Epigenetics 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 standard staging surgical intervention and follow up care Tissue blood andor peritonealpleural effusion samples obtained during surgerybiopsy 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 After recovery from biopsy or surgery patients will continue to be followed blood and urine samples may 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 undergo standard of care treatment at the NIH Clinical Center on this study
It is anticipated that the protocol will enroll a maximum of 1310 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-C-0014 | None | None | None |