Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry

NCT07732686 | Not Yet Recruiting

• 1 other identifier: OU-SCC-VOC
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Cancer; Hepatocellular Carcinoma; Lung Cancer; Ovarian Cancer; Breast Cancer; Head and Neck Cancer; Colon Cancer; Bladder Cancer; Other Cancer

Keywords

VOC; PTR-MS; ML

Outcome Measures

Primary Outcomes (2)

• VOC Signature Collection.

  The successful collection of breath samples from 1000 cancer patients and 1000 healthy volunteers.

  2 Years

• 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

Secondary Outcomes (1)

• Assess The Specificity and Accuracy of ML Analysis In The Test Dataset.

  1 year

Study Arms (2)

Diagnosed Malignancies

Participants in this group either have a newly diagnosed, untreated cancer or a pre-existing cancer diagnosis but are not currently receiving anticancer therapy. Participants with a pre-existing diagnosis must not have received any anticancer treatment within the previous month.

Device: Proton Transfer Reaction Mass Spectrometry Analysis

Healthy Control Group

Participants in this control group have no current or prior diagnosis of a malignancy.

Device: Proton Transfer Reaction Mass Spectrometry Analysis

Interventions

Proton Transfer Reaction Mass Spectrometry Analysis DEVICE

This is a noninvasive intervention. Participants will be asked to provide a breath sample using a disposable mouthpiece equipped with a saliva/moisture 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.

Also known as: PTR-MS

Diagnosed Malignancies; Healthy Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with malignancies and healthy individuals who meet the inclusion criteria.

You may qualify if:

• Age ≥ 18 at the time of consent. Male and female patients to be tested.
• Capable of understanding written and/or 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Carcinoma, Hepatocellular; Lung Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Colonic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Nirmal Choradia, MD

  University of Oklahoma - Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Nirmal Choradia, MD

CONTACT

Nirmal-Choradia@ouhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)