Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Morningside Holdings Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Cohort 1 Participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant female participant aged between 18 to 80 years (both inclusive) 2. Participant with biopsy proven oesophageal squamous cell cancer or oesophageal/gastrooesophageal junction adenocarcinoma who are awaiting treatment. 3. Participant agrees to comply with the study requirements and provide written informed consent to participate in the study. Cohort 2 Participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant female participant aged between 18 to 80 years (both inclusive). 2. Participant with benign conditions or normal gastrointestinal tract with upper gastrointestinal symptoms determined by endoscopy within 1 year. 3. Participant agrees to comply with the study requirements and provide written informed consent to participate in the study. Cohort 3 Participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant female participant aged between 18 to 80 years (both inclusive). 2. Participant with suspected oesophageal squamous cell cancer or oesophageal/gastrooesophageal junction adenocarcinoma who is awaiting biopsy result to confirm presence of squamous cell cancer or adenocarcinoma. 3. Participant agrees to comply with the study requirements and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Cohort 1 Participant will not be eligible for inclusion in this study if any of the following criteria apply: 1. Participant with previous oesophageal and gastric resection. 2. Participant who has received neoadjuvant chemotherapy for oesophageal or gastric cancer. 3. Participant with a history of another cancer within three years. 4. Participant with an active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks. 5. Participant with co-morbidities preventing breath collection. 6. Participant with allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, maltodextrin (corn, potato), xanthan gum, potassium chloride, tyrosine, phenylalanine, and glutamic acid. 7. Female participant who is pregnant, breast feeding, or planning a pregnancy. 8. Female of childbearing potential who does not agree to utilize an adequate form of contraception during the study duration. 9. Participant has previously been enrolled in this study. 10. Any other condition that, in the investigator s judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. Cohort 2 Participant will not be eligible for inclusion in this study if any of the following criteria apply: 1. Participant with an oesophageal squamous cell carcinoma. 2. Participant with previous oesophageal and gastric resection. 3. Participant who has received neoadjuvant chemotherapy for oesophageal or gastric cancer. 4. Participant with a history of another cancer within three years. 5. Participant with any form of oesophageal dysplasia. 6. Participant with previously diagnosed with Barrett s oesophagus. 7. Participant with an active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks. 8. Participant with co-morbidities preventing breath collection. 9. Participant with allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, maltodextrin (corn, potato), xanthan gum, potassium chloride, tyrosine, phenylalanine, and glutamic acid. 10. Female participant who is pregnant, breast feeding, or planning a pregnancy. 11. Female of childbearing potential who does not agree to utilize an adequate form of contraception during the study duration. 12. Participant has previously been enrolled in this study. 13. Any other condition that, in the investigator s judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. Cohort 3 Participant will not be eligible for inclusion in this study if any of the following criteria apply: 1. Participant with previous oesophageal and gastric resection. 2. Participant who has received neoadjuvant chemotherapy for oesophageal or gastric cancer. 3. Participant with a history of another cancer within three years. 4. Participant with an active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks. 5. Participant with co-morbidities preventing breath collection. 6. Participant with allergies to any of the constit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinical prediction model to detect oesophageal cancer based on difference in VOCs between oesophageal cancer and non-cancer participants. Timepoint: 24 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Incidence of adverse events (AEs) and serious adverse events (SAEs). Incidence of adverse events (AEs) and serious adverse events (SAEs) will be summarized by count (n) and percentage in the two groups separately and combined. b. The variation in VOCs following the consumption of OSD. Variation in VOCs will be analyzed by descriptive statistics. Above analysis will be performed on the safety population. Detailed statistical methodology will be prepared in the Statistical Analysis plan (SAP). Timepoint: 24 hr | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed