Health Condition 1: Z12- Encounter for screening for malignant neoplasms Health Condition 2: Z139- Encounter for screening, unspecified Health Condition 3: Z77-Z99- Persons with potential health hazards related to family and personal history and certain conditions influencing health status Health Condition 4: Z720- Tobacco use Health Condition 5: F17- Nicotine dependence Health Condition 6: F10- Alcohol related disorders Health Condition 7: Z14-Z15- Genetic carrier and genetic susceptibility to
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Dognosis India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Cohort A: High Risk screening group 35 years and above Individuals undergoing standard-of-care cancer screening for early detection (e.g., mammograms, colonoscopies, lung imaging). Recruitment would prioritize high risk population including following high-risk criteria: Asymptomatic high risk : (e.g. persistent use of tobacco (smoke or smokeless, Heavy alcohol consumption, Occupational or environmental exposure (e.g., asbestos, radon, industrial solvents) , Obesity or metabolic syndrome (linked to increased risk for multiple cancers) Cancer predisposition according to National Comprehensive Cancer Network (NCCN) guidelines for germline testing or known hereditary cancer syndrome. (Ref. NCCN Guidelines Insights: Genetic or Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, Version 2.2024 and Genetic or Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric Version 3.2024 October 31, 2024) First-Degree Relatives of Cancer Patients: Especially those with early-onset or multiple primary cancers, History of cancers across multiple generations or Family clustering of similar cancer types Further refer to EHR based LLM risk assessment. Cohort B: Suspected Malignancy Group 18 years and above Individuals undergoing diagnostic procedures (e.g., biopsy) due to clinical suspicion of malignancy, such as suspicious imaging findings or abnormal screening test results. Cohort C: Pre and Post treatment cohort with follow up samples 18 years and above Adults diagnosed with cancer with stage I-IV (breast, cervical, ovarian, colorectal, esophageal, stomach or head & neck ) scheduled for chemotherapy and/or surgical intervention. (optional) Patients who have completed curative-intent treatment (surgery, chemotherapy, and/or radiotherapy) Patients who are currently declared disease-free, in complete remission, or with no clinical evidence of disease (NED). Willingness to comply with the study protocol and follow-up schedule.
Exclusion criteria
Exclusion criteria: Contagious Respiratory Diseases: Participants diagnosed with communicable diseases, such as Tuberculosis (TB), that may be transmitted via breath or sputum. (Active respiratory infections such as tuberculosis (TB), influenza, COVID-19, and other transmissible respiratory diseases.) Severe Co-morbid Conditions: Participants with severe co-morbid conditions that may interfere with the study or its outcomes (e.g., advanced dementia, severe cognitive impairments, or other conditions that compromise the ability to provide informed consent or follow study protocols). Pregnancy: Females who are pregnant or have given birth within the last three months. Recent Medical Procedures: Participants who have undergone a medical procedure involving the thorax or airways (e.g., lung biopsy, thoracic surgery, or respiratory interventions) within the past two weeks. Ongoing Health Conditions: a) Participants with an active Helicobacter pylori infection or a gastric ulcer. b) Participants experiencing a flare of inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis) or any ongoing active infection at the time of participation. Concurrent malignancies or previous cancer treatments within the last five years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort wise Sensitivity and Specificity , Positive Predictive Value, Negative Predictive ValueTimepoint: After Year 1, Year 2 and Year 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Lead Time analysis for Cohort CTimepoint: at the end of the study period. (3 years);Cancer type wise test performance for accuracyTimepoint: After Year 1, Year 2 and Year 3;Evaluating the Feasibility of Implementing BreathEasy in Community-Level Screening Camps for cohort A Timepoint: After Year 1, Year 2 and Year 3 | — |
Countries
India
Contacts
Public ContactAkash Kulgod
Dognosis India Private Limited
Outcome results
None listed