[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732686":3,"trial-entities:NCT07732686":112,"trial-summary:NCT07732686":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":28,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":47,"secondary_outcomes":56,"sex":61,"minimum_age":62,"maximum_age":33,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":82,"locations":85,"central_contacts":100,"overall_officials":106,"references":110,"see_also_links":111},"NCT07732686","OU-SCC-VOC","Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry","Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)","NOT_YET_RECRUITING","2029-10","2026-07","2026-07-29","2026-10","University of Oklahoma","OTHER",false,"The purpose of this clinical trial is to evaluate whether volatile organic compound (VOC) signatures detected in the breath of patients with cancer can serve as a potential screening tool for the early detection of cancer.","This study aims to determine whether metabolic changes associated with cancer produce distinct alterations in exhaled breath compared with those of healthy individuals. Breath samples will be analyzed using machine learning techniques to identify volatile organic compound (VOC) patterns and develop diagnostic algorithms capable of detecting multiple types of cancer. The long-term goal is to establish a noninvasive, breath-based screening tool that can facilitate the early detection of various cancers.\n\nAdditionally, patients and healthy participants who consent to this study may opt in to be contacted in the future to provide additional breath samples.",[19,20,21,22,23,24,25,26,27],"Pancreas Cancer","Hepatocellular Carcinoma","Lung Cancer","Ovarian Cancer","Breast Cancer","Head and Neck Cancer","Colon Cancer","Bladder Cancer","Other Cancer",[29,30,31],"VOC","PTR-MS","ML","OBSERVATIONAL",null,[],{"count":36,"type":37},2000,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":46},"DEVICE","Proton Transfer Reaction Mass Spectrometry Analysis","This is a noninvasive intervention. Participants will be asked to provide a breath sample using a disposable mouthpiece equipped with a saliva\u002Fmoisture trap and a non-rebreathing valve. Breath samples will be collected through normal, steady exhalation. The entire breath collection process is expected to take no more than 30 minutes to complete.",[44,45],"Diagnosed Malignancies","Healthy Control Group",[30],[48,52],{"measure":49,"description":50,"timeFrame":51},"VOC Signature Collection.","The successful collection of breath samples from 1000 cancer patients and 1000 healthy volunteers.","2 Years",{"measure":53,"description":54,"timeFrame":55},"Assess the sensitivity of Machine Learning (ML) Algorithm In The Test Dataset.","Using the training dataset, qualitative output generated by the PTR-MS instrument will be analyzed using machine learning methods to identify volatile organic compound (VOC) patterns associated with different cancer types, including pancreatic, esophageal, hepatocellular carcinoma, lung, and ovarian cancers. The trained machine learning model will be tested using the dataset.","1 Years",[57],{"measure":58,"description":59,"timeFrame":60},"Assess The Specificity and Accuracy of ML Analysis In The Test Dataset.","To determine the specificity, and overall diagnostic accuracy of the machine learning (ML) algorithm for detecting pancreatic, esophageal, hepatocellular carcinoma, lung, and ovarian cancers within the test dataset.","1 year","ALL","18 Years",true,{"inclusion":65,"exclusion":71,"raw_text":81},[66,67,68,69,70],"Age ≥ 18 at the time of consent. Male and female patients to be tested.","Capable of understanding written and\u002For spoken English language.","Able to provide informed consent.","Cancer of any type.","Newly diagnosed cancer and untreated or established diagnosis of cancer. For established cancer patients, no active anti-cancer treatment for more than one month (reasons for no treatment are such as relapse, progression of cancer, refractory, or intolerance to treatment etc.)",[72,73,74,75,76,77,78,79,80],"Under the age of 18.","Anticipated inability to complete breath sampling procedure.","Unable to provide informed consent.","Pregnant women","Active respiratory infection symptoms","Recent use of antibiotics","Difficulty in performing coached exhalation","Individuals who are unable to follow the instructions","Cancer patients who are on active treatment for cancer or have received cancer treatment within one month","Inclusion Criteria:\n\n* Age ≥ 18 at the time of consent. Male and female patients to be tested.\n* Capable of understanding written and\u002For spoken English language.\n* Able to provide informed consent.\n* Cancer of any type.\n* Newly diagnosed cancer and untreated or established diagnosis of cancer. For established cancer patients, no active anti-cancer treatment for more than one month (reasons for no treatment are such as relapse, progression of cancer, refractory, or intolerance to treatment etc.)\n\nExclusion Criteria:\n\n* Under the age of 18.\n* Anticipated inability to complete breath sampling procedure.\n* Unable to provide informed consent.\n* Pregnant women\n* Active respiratory infection symptoms\n* Recent use of antibiotics\n* Difficulty in performing coached exhalation\n* Individuals who are unable to follow the instructions\n* Cancer patients who are on active treatment for cancer or have received cancer treatment within one month",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":97},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73117","United States",[93],{"name":94,"role":95,"email":96},"Nirmal Choradia, MD","CONTACT","Nirmal-Choradia@ouhsc.edu",{"lat":98,"lon":99},35.46756,-97.51643,[101,105],{"name":102,"role":95,"phone":103,"email":104},"Lead Onco Nurse","405-271-8777","SCC-IIT-Office@ouhsc.edu",{"name":94,"role":95,"email":96},[107],{"name":94,"affiliation":108,"role":109},"University of Oklahoma - Stephenson Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":122},[114,115,116,20,117,118,119,120,121],"Bladder Carcinoma","Breast Carcinoma","Colon Carcinoma","Lung Carcinoma","Malignant Head and Neck Neoplasm","Malignant Ovarian Neoplasm","Malignant Pancreatic Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":63,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an observational study, meaning participants will be observed without receiving a specific treatment. It aims to enroll 2000 participants.","completed","Breath Analysis for Cancer Detection","This study is looking at whether a breath test can help find different types of cancer early, including pancreas, liver, lung, ovarian, and breast cancer. Researchers will collect your breath samples using a simple mouthpiece. They will then analyze these samples using a special device called Proton Transfer Reaction Mass Spectrometry Analysis to look for specific patterns of chemicals (volatile organic compounds or VOCs) in your breath. The goal is to see if these patterns can help create a screening tool to detect cancer. You can join if you are 18 or older, understand English, and have a new or existing cancer diagnosis. The study hopes to enroll 2000 participants.","The study will collect VOC signatures over 2 years and assess the accuracy of a machine learning algorithm over 1 year.",110,"You will be asked to provide a breath sample by exhaling normally into a disposable mouthpiece. You may also be asked to provide additional breath samples in the future.","Not stated in the trial record.",[41],"v2"]