| CTRI Number |
CTRI/2024/03/063799 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Kozhnosys developed by the CanScan prototype is being utilized in an observational study to collect and analyze volatile markers in the exhaled breath of cancer (GI, Cervical, Colorectal, head and neck) patients. |
|
Scientific Title of Study
|
An observational study to collect and analyze volatile markers in the exhaled breath of cancer (GI, Cervical, Colorectal, head, and neck) patients using the CanScan prototype developed by
Kozhnosys. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shona Nag |
| Designation |
Director Oncology |
| Affiliation |
Sahyadri Super Speciality Hospital |
| Address |
Sahyadri Super Specialty Hospital, Hadapsar, Sr. No. 63, Bhosale Nagar, Hadapsar 411028, Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
9371072441 |
| Fax |
|
| Email |
shonanag3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jilma Peruvangat |
| Designation |
Director |
| Affiliation |
Kozhnosys. Pvt. Ltd |
| Address |
803, A-15, Xrbia Hinjewadi, Nere Dattawadi, Pune
MAHARASHTRA
412115
India
Pune
MAHARASHTRA
412115
India |
| Phone |
9833482033 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
Details of Contact Person
Public Query
|
| Name |
Jilma Peruvanagt |
| Designation |
Director |
| Affiliation |
Kozhnosys. Pvt. Ltd |
| Address |
803, A-15, Xrbia Hinjewadi, Nere Dattawadi, Pune, MAHARASHTRA-412115
India
Pune
MAHARASHTRA
412115
India |
| Phone |
9833482033 |
| Fax |
|
| Email |
jilma@kozhnosys.com |
|
|
Source of Monetary or Material Support
|
| Company (Start-up)
Company Name-Kozhnosys Private Limited.
Address-803, A-15, Xrbia Hinjewadi, Nere Dattawadi-412115 |
|
|
Primary Sponsor
|
| Name |
Kozhnosys Private Limited |
| Address |
Kozhnosys Private Ltd. 803, A-15, Xrbia Hinjewadi, Nere Dattawadi-412115
Pune |
| Type of Sponsor |
Other [Biomedical Research Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shona Nag |
Sahyadri Multispecialty Hospital, Research and Development Center |
33/34 B, Makarand Bhave Path, Karve rd, Erandawane, Pune,
Pune
MAHARASHTRA |
9371072441
shonanag3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sahyadri Hospital Pvt. Ltd. Biomedical and Health Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R978||Other abnormal tumor markers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria for GI, Cervical, Colorectal, head, and neck Cancer
1. Willing to fill out the informed consent form
2. Female in the age group 20 to 80 years Women with newly diagnosed cancer (GI, Cervical, Colorectal, head, and neck) with/without common medical conditions like Hypertension, Hyperlipidaemia, Hypothyroidism, Arthritis, Asthma, GERD, Diabetes, PCOD, Vitamin deficiencies, etc. -20 evaluable subjects (4 patients each with above-mentioned cancer)
3. Confirmed cases of GI, Cervical, Colorectal, head, and neck cancer but not exposed to any previous treatment cycle/surgery.
4. Cases confirmed through endoscopy, PAP smear, Colonoscopy, MRI/CT, Ultrasonography or blood tests.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria for GI, Cervical, Colorectal, head, and neck cancer
1. The age group is below 20 years.
2. Any known illness within 2 weeks from breath collection.
3. Already undergoing cancer treatment.
4. Undergone surgery for cancer tumor removal.
5. Undergoing chemo/radiation therapy for cancer treatment.
6. Positive, but no GI, Cervical, Colorectal, head, and neck cancer on the later investigation (Positive Sonography but negative biopsy report).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VOC (Volatile organic compounds) profile in GI, colorectal, cervical, Head & neck cancers. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Detection of volatile markers of biomarkers in GI, Colorectal, Cervical, Head, and Neck cancers using Canscan prototype.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study to analyze and discover volatile markers of cancer in exhaled breaths of GI, Colorectal, cervical, and Head & Neck cancers. The exhaled breath of these cancer patients will be collected using the CanSacn prototype developed by Kozhnosys. The exhaled breath will be analyzed using GC-MS and CanScan prototype sensors developed by Kozhnosys. The concentration of these markers will be determined using GC-MS and correlated with sensor responses. The profile of volatile markers of each of these cancers will be noted for future research studies. |