Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Rare Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Lung Neoplasms

Lung Diseases

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Non-smokers (n=20), Smokers (n=20) and Individuals with lung cancer (n=20)

Subjects with abnormalities (nodules) detected on CT (n=20)

Perform gene expression studies of airway epithelium to correlate findings in the gene expression of nasal bronchial epithelium

Group 1

Correlate gene expression data from nasal and bronchial epithelium

Group 2

Correlated nasal epithelial gene expression with the ultimate diagnosis (by biopsy or surgery)

Group 3

Ronald G Crystal, MD

Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role. This study proposes to examine the genetic correlation between nasal and bronchial epithelium and to identify a patient's risk for lung cancer earlier.

Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role.

Without screening, lung cancer is only detected at an early stage 10% of the time, translating into a 7% cure rate. Published studies of screening for lung cancer using CT scans show that it is detectable at an early stage 85% of the time, translating into a cure rate over 60%. However, in a sample population of 1000 smokers over the age of 60 (high risk individuals), 233 will have suspicious abnormalities on CT scans, but only 27 had lung cancer. Two concerns are apparent. First, among the 233 individuals with suspicious abnormalities on CT, how does one choose the ones suspicious enough for biopsy, surgery, or other invasive procedures? Generally, follow-up CT scans over several months are used to assess the abnormalities for growth, since growth is a characteristic of malignancy. Unfortunately, repeated CT scans involve financial cost and potential radiation risk. An additional technique which is able to predict predisposition to lung cancer, if combined with the ability of CT scans to detect abnormalities in real time, could prove to be a powerful platform to efficiently screen for lung cancer and reduce its mortality.

Lung cancer develops as a consequence of a series of genetic injuries to the cells lining the airways which cause these bronchial cells to grow in a malignant manner, unchecked, resistant to normal homeostatic controls. By studying the gene expression signature of airway (bronchial) lining cells, differences are observed between normal nonsmokers, individuals exposed to smoke second-hand, and smokers who have developed COPD (chronic bronchitis and emphysema). Some genetic changes in bronchial lining cells near a lung cancer are specific to lung cancer --- the "field effect." Obtaining bronchial lining cells for genetic analysis requires an invasive and expensive procedure, fiberoptic bronchoscopy, and therefore bronchoscopically acquired bronchial lining cells are not suitable for screening of the public for lung cancer.

The lining cells of the nose, the nasal epithelium, which is part of the human airway, have many similarities to bronchial epithelium, but they are much more accessible. A gentle scraping of the nasal lining involves no risk to the patient, less cost, and, it is hoped, will provide the same genetic information as the bronchial lining cells.

This study proposes to examine the genetic correlation between nasal and bronchial epithelium in the hopes of developing an office-based test to identify a patient's risk for lung cancer. It is hoped that the genetic analysis of nasal epithelium may be combined with the other risk factors for lung cancer such as cigarette smoking, age over 50 years, and an obstructive ventilatory impairment noted on pulmonary function tests to find the ideal (or enriched) population to screen with CT to detect early lung cancer, thus reducing the financial cost, radiation exposure, and risk of invasive procedures to a minimum, furthering the ultimate goal of "personalized medicine."

Blood, urine and cells obtained for this study may be retained for future research with given consent.

Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer

Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis

Weill Medical College of Cornell University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Analgesics, Opioid

Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery

Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.

Participants will receive standard general anesthesia alone. You will not receive hypnosedation.

Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery

Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room

Participants will receive standard general anesthesia and medications during surgery to control your pain.

Lorenzo Cohen, MD

To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.

OBJECTIVES

The proposed trial will randomize women and men with stage 0/I breast cancer scheduled for a lumpectomy ± sentinel node biopsy to one of three groups: 1) surgery with a local anesthetic, fentanyl, and HS before and during surgery (HS); 2) HS before surgery with usual care general anesthesia (HS-GA; total intravenous anesthesia rendering the patient unconscious with propofol infusion, airway instrumentation with a laryngeal mask airway or endotracheal tube, fentanyl, and local anesthetic); or 3) Usual care general anesthesia same as HS-GA group (GA). This project will allow further exploration of HS during surgery and to explore the biopsychosocial processes associated with analgesia and opioid use, anesthesia, and pain. We will test the hypotheses that HS during breast cancer surgery leads to reduced analgesia and opioid use, less pain and psychological stress, and faster recovery, as well as being more cost effective than GA or HS before surgery with GA.

Primary Objective:

To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.

Secondary Objectives:

* To determine the efficacy of HS with local anesthesia vs HS-GA or GA on reducing self-reported and objective pain, anxiety, nausea/vomiting, fatigue, and cognitive dysfunction.
* To evaluate group differences in costs. Using time and motion studies and methods of economic evaluation, we will test the hypothesis that HS before and during surgery will lead to less time spent in the OR and PACU, lower medication use, and less need for clinical staff engagement, leading to lower overall day of surgery-related costs.
* To explore psychosocial factors as moderators of the effects of the intervention and predictors of recovery. Baseline psychosocial factors including absorption, state and trait anxiety, intrusive thoughts, and discomfort intolerance, pain sensitivity, and expectations will moderate the effects of HS and predict outcomes over time.

Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

Trait/State Anxiety Questionnaire will be assessed with the 40-item Spielberger State Trait Anxiety Inventory (STAI)53. The STATE scale is a 20-item scale that provides information about a person's current level of anxiety. The TRAIT scale is a 20-item scale that provides information about a person's general anxiety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer	NCT01982149	Chronic Obstruc... COPD	Group 1 Group 2 Group 3	18 Years -	Weill Medical College of Cornell University
Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer	NCT01982149	Chronic Obstruc... COPD	Group 1 Group 2 Group 3	18 Years -	Weill Medical College of Cornell University
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery	NCT05766891	Breast Cancer	Group 1 Group 2 Group 3	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for group 3

Every month we try and update this database with for group 3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for group 3

Every month we try and update this database with for group 3 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for group 3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.