| CTRI Number |
CTRI/2023/04/051268 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to analyse relationship between gut microbiome and different types of lung cancers |
|
Scientific Title of Study
|
Relationship between gut microbiome and different types of lung cancers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nirmal Raut |
| Designation |
Consultant Medical Oncologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No.3, 1st Floor, Bhaktivedanta Hospital and Research Institute, Srishti Complex,Bhaktivedanta Swami Marg,Mira Road (East),Thane-401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9930398156 |
| Fax |
|
| Email |
pinirmal123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirmal Raut |
| Designation |
Consultant Medical Oncologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No.3, 1st Floor, Bhaktivedanta Hospital and Research Institute, Srishti Complex,Bhaktivedanta Swami Marg,Mira Road (East),Thane-401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9930398156 |
| Fax |
|
| Email |
pinirmal123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaykumar Gawali |
| Designation |
Head Of Department- Clinical Research and Education |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
5th Floor, Medical Research Department,Bhaktivedanta Hospital and Research Institute, Srishti Complex,Bhaktivedanta Swami Marg,Mira Road (East),Thane-401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9320199122 |
| Fax |
|
| Email |
drvijaykumar.g@bhaktivedantahospital.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Hospital & Research Institute,Srishti Complex,Bhaktivedanta Swami Marg,Mira Road (East),Thane-401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijaykumar Gawali |
Bhaktivedanta Hospital and Research Institute |
3rd Floor,Medical Research Department,Srishti Complex,Bhaktivedanta Swami Marg,Mira Road (East),Thane-401107
Thane
MAHARASHTRA |
9320199122
drvijaykumar.g@bhaktivedantahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers not having EGFR activating lung cancer |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have lung cancer with EGFR activating mutations. |
|
| ExclusionCriteria |
| Details |
Patient who is not able to provide stool sample for analysis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The different microbiota in different percentage present in EGFR positive lung cancers will establish that diet forms a major contributing factor in non-smoking related lung cancers.
|
The outcome will be assessed at 4 weeks for the duration of 1 year |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
24/04/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective observational study to analyze the relationship between gut microbiome and different types of lung cancers. This study involves three groups- Group 1 will comprise of smoker NSCLC patients, Group 2 will consist of non-smoker EGFR mutated NSCLC and Group 3 comprises of control patients (no cancer). 30g of stool sample of patients of different lung cancers and normal volunteers will be collected for RNA sequencing to check for various gut microbiota. A preliminary 25 patients will be included in each cohort. The expected outcome of the study is that different microbiota in different percentages in EGFR positive lung cancers will establish that diet forms a major contributing factor in non-smoking related lung cancers. |