Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352391
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2006-07-12
Brief Title:
Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer NSCLC Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Vanguard Study Characterizing Occurrence of Recurrent or Second Primary Tumors in Patients With Prior History of Definitively Treated Stage III Head and Neck or Non-Small Cell Lung Cancer Who Are Current or Former Smokers
Status:
COMPLETED
Status Verified Date:
2016-02
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:
The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population This will be done by studying characteristics of tissue and bodily fluids including blood
Objectives
To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage III lung or head and neck cancer
To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population
Objectives
To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage III lung or head and neck cancer
To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population
Detailed Description:
This study is known as the Vanguard Trial When you enter this study you will have a complete medical history including smoking history and physical exam including measurement of height weight and vital signs including blood pressure heart rate and temperature You will have a performance status evaluation a test looking at the ability to perform every day activities You will have blood samples drawn for routine blood tests about 3 teaspoons to check your blood clotting function about 1-2 teaspoons and for research purposes about 4 teaspoons You will have a chest x-ray and a CT scan of your chest Women who are able to have children must have a negative blood or urine pregnancy test If you are currently a smoker you will be given information on programs to help you quit smoking Although you will be encouraged to quit smoking you do not have to quit smoking or participate in these programs to be a part of this study
You will also have a bronchoscopy tissue sample from the lung at the beginning of this study for lab analysis For this procedure you will be given drugs to relax Then a local anesthetic will be sprayed in your nose and throat to numb those areas A slim flexible tube with a light will be placed through your nose or mouth and into your lungs Tweezers will be fed through the tube to collect lung tissue biopsy samples from 6 different places in your lungs During the bronchoscopy procedure a complete inspection of the airways will be performed Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present You will also have a bronchial brushing next to each biopsy site In a bronchial brushing a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off When the biopsies and brushings are done you will have a bronchial lavage bronchial washing In the bronchial lavage a small amount of water about 4 tablespoons is sprayed into your lungs and then suctioned out through the tube This fluid is used to collect additional tissue and mucous samples In addition a sputum saliva sample will be taken and the inside of your cheek will be scraped buccal sample
If you have had HNSCC you will also have a laryngoscopy In a laryngoscopy a lighted tube is placed down your throat and the larynx is checked The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable
While on study you will return to the clinic for at least 3 years and for up to a total of 6 years At Months 6 12 18 24 30 and 36 your complete medical history will be recorded and you will have a physical exam by either a doctor or a nurse At each of these visits you will also have blood drawn for routine tests about 3 teaspoons and for research purposes about 4 teaspoons You will also have a chest x-ray and a chest CT at these visits At Months 12 24 and 36 you will have blood drawn about 1-2 teaspoons to check your blood-clotting function If you think you may be pregnant you will also have a urine or blood pregnancy test In addition you will have a bronchoscopy and provide sputum and buccal smear samples at your 12 month visit If you have been treated for HNSCC you will have a laryngoscopy at 12 months
You have the right to leave the study at any time If you choose to stop participating in this study you will be asked to return to the clinic for a final clinic visit At this visit your complete medical history will be recorded and you will have a physical exam and blood drawn for routine tests about 3 teaspoons and for research purposes about 4 teaspoons Your study doctor will also ask you about your current smoking use any medications you are taking and how you are feeling symptoms
This research study includes two bronchoscopies done one year apart These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment These bronchoscopies do have risks associated with them These risks are described in section 4 of this informed consent document
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs However this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy you may only enroll in the Vanguard study after you have completed the adjuvant chemotherapy
As part of this study you will provide samples of your lung tissue saliva blood and scrapings from the inside of your cheek Fluid and mucous collected during the bronchoscopies will also collected These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs These cells and cultures will also be used to learn about genes and proteins
All M D Anderson researchers are trained in the importance of maintaining patient privacy Your privacy will be protected by assigning you a number that will be used in place of your name on documents that are part of this study A list that links your name with your study number will be stored in a restricted file that may be accessed only with a password Only a few essential research personnel have access to this password
At the end of the study you will not be automatically notified of the research findings If you wish to learn about the results however you may request them from the principal investigator
Principal Investigator Waun Ki Hong MD 1515 Holcombe Blvd Unit 432 MD Anderson Cancer Center Houston TX 77030
This is an investigational study A total of about 50 individuals will take part in this study Participants will be enrolled at M D Anderson and several other sites around the country
You will also have a bronchoscopy tissue sample from the lung at the beginning of this study for lab analysis For this procedure you will be given drugs to relax Then a local anesthetic will be sprayed in your nose and throat to numb those areas A slim flexible tube with a light will be placed through your nose or mouth and into your lungs Tweezers will be fed through the tube to collect lung tissue biopsy samples from 6 different places in your lungs During the bronchoscopy procedure a complete inspection of the airways will be performed Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present You will also have a bronchial brushing next to each biopsy site In a bronchial brushing a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off When the biopsies and brushings are done you will have a bronchial lavage bronchial washing In the bronchial lavage a small amount of water about 4 tablespoons is sprayed into your lungs and then suctioned out through the tube This fluid is used to collect additional tissue and mucous samples In addition a sputum saliva sample will be taken and the inside of your cheek will be scraped buccal sample
If you have had HNSCC you will also have a laryngoscopy In a laryngoscopy a lighted tube is placed down your throat and the larynx is checked The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable
While on study you will return to the clinic for at least 3 years and for up to a total of 6 years At Months 6 12 18 24 30 and 36 your complete medical history will be recorded and you will have a physical exam by either a doctor or a nurse At each of these visits you will also have blood drawn for routine tests about 3 teaspoons and for research purposes about 4 teaspoons You will also have a chest x-ray and a chest CT at these visits At Months 12 24 and 36 you will have blood drawn about 1-2 teaspoons to check your blood-clotting function If you think you may be pregnant you will also have a urine or blood pregnancy test In addition you will have a bronchoscopy and provide sputum and buccal smear samples at your 12 month visit If you have been treated for HNSCC you will have a laryngoscopy at 12 months
You have the right to leave the study at any time If you choose to stop participating in this study you will be asked to return to the clinic for a final clinic visit At this visit your complete medical history will be recorded and you will have a physical exam and blood drawn for routine tests about 3 teaspoons and for research purposes about 4 teaspoons Your study doctor will also ask you about your current smoking use any medications you are taking and how you are feeling symptoms
This research study includes two bronchoscopies done one year apart These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment These bronchoscopies do have risks associated with them These risks are described in section 4 of this informed consent document
Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs However this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy you may only enroll in the Vanguard study after you have completed the adjuvant chemotherapy
As part of this study you will provide samples of your lung tissue saliva blood and scrapings from the inside of your cheek Fluid and mucous collected during the bronchoscopies will also collected These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs These cells and cultures will also be used to learn about genes and proteins
All M D Anderson researchers are trained in the importance of maintaining patient privacy Your privacy will be protected by assigning you a number that will be used in place of your name on documents that are part of this study A list that links your name with your study number will be stored in a restricted file that may be accessed only with a password Only a few essential research personnel have access to this password
At the end of the study you will not be automatically notified of the research findings If you wish to learn about the results however you may request them from the principal investigator
Principal Investigator Waun Ki Hong MD 1515 Holcombe Blvd Unit 432 MD Anderson Cancer Center Houston TX 77030
This is an investigational study A total of about 50 individuals will take part in this study Participants will be enrolled at M D Anderson and several other sites around the country
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None