Room No: Ward no. 9 Second Floor at PGIMS Emergency Building Pt. B. D. Sharma PGIMS Rohtak Haryana 124001.
Department: Department of medicine
Division: Gastroenterology Rohtak HARYANA
9825433984
globalhospitalcr@gmail.com
Dr Shyam Aggarwal
Sir Ganga Ram Hospital
Room no-3012 E block at Sir Ganga Ram hospital at oncology department, ( senior consultant & chairperson medical oncology) Rajinder Nagar, New Delhi- 110060 India.
Department: Medical Oncology department ,Oncologist & Hematologist
Division: oncology New Delhi DELHI
9811075870
drshyam_aggarwal@yahoo.com
Dr Tejas Modi
Zydus Hospital and healthcare Research Pvt Ltd
Room No: Second floor, OPD No:B11, B wing Second floor,
Department: Gastroenterology department, Zydus Hospitals Road, Sarkhej - Gandhinagar Highway, Near Sola Bridge, Ahmedabad- 380054, Gujarat, India.
Division: Gastroenterology Ahmadabad GUJARAT
Institutional Ethics Committee Asian Institute of Gastroenterology
Approved
Institutional Ethics Committee DR. S.N. MEDICAL COLLEGE
Submittted/Under Review
Institutional ethics Committee, PGIMS UHS Rohtak
Approved
Kaizen Ethics Committee
Approved
Mangalmurti Institutional Ethics Committee
Approved
Sir Ganga Ram Ethics Committee
Approved
Zydus Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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 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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
A clinical prediction model to detect oesophageal cancer based on difference in VOCs between oesophageal cancer and non-cancer participants.
24 hr
Secondary Outcome
Outcome
TimePoints
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).
24 hr
Target Sample Size
Total Sample Size="1350" Sample Size from India="1350" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is a multicenter,
randomized, observational study to develop a clinical prediction model (CPM) to
detect oesophageal cancer based on the volatile organic compounds (VOCs) observed
in exhaled breath and to examine its diagnostic accuracy. This study has 2
phases - Screening period, breath sample collection phase. At the randomization
visit, participants who meet all of the eligibility criteria will be randomized
to receive oral stimulant drink (OSD) after collection of baseline breath
sample collection. Post drinking OSD, at 15 min another breath sample will be
collected. The augmented response of specific VOCs in the exhaled breath for
detecting oesophageal cancer will also be observed along with assessing the
safety and tolerability related to the consumption of the oral stimulant drink
(OSD) in the study participants.