| CTRI Number |
CTRI/2024/04/065776 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Exploring the Relationship Between Gut Bacteria and Lung Cancer Treatment in India: A prospective observational Study on How Gut Microbes Influence Immunotherapy Effects" |
|
Scientific Title of Study
|
A Prospective Observational Study to evaluate the Gut Microbiome status in Indian advanced Non-Small Cell Lung Cancer Patients receiving Immunotherapy and investigate potential correlations between the gut microbiome composition and treatment outcomes |
| 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 Akhil Kapoor |
| Designation |
Associate professor, Department of Medical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Department of Medical oncology, OPD room No.28 Ground floor DNT Block, Mahamana Pandit Madan
Mohan Malaviya Cancer Centre (MPMMCC) Sundarpur Varanasi
UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9950482121 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhil Kapoor |
| Designation |
Associate professor, Department of Medical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
OPD No.28 Ground floor DNT Block,Mahamana Pandit Madan
Mohan Malaviya Cancer Centre (MPMMCC) Sundarpur Varanasi
UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9950482121 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Chaudhary |
| Designation |
Senior Resident |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
OPD No.11 Ground floor DNT Block,Mahamana Pandit Madan
Mohan Malaviya Cancer Centre (MPMMCC) Sundarpur Varanasi
UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8058691191 |
| Fax |
|
| Email |
chaudharymahesh783@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre. BHU Campus, Naria Rd. Sundar Bagiya Colony. Varanasi, Uttar Pradesh - 221005 |
| 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 Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Department of medical oncology, OPD room no 22, Mahamana Pandit Madan Mohan Malaviya Cancer Centre. BHU Campus, Naria Rd. Sundar Bagiya Colony. Varanasi, Uttar Pradesh - 221005
Varanasi
UTTAR PRADESH |
9950482121
kapoorakhil1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Homi Bhabha Cancer Hospital (HBCH) and Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who were willing to participate (via written consent form) in the study.
2. Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
3. Age more than 18 years at the time of the study.
4. PD-L1 tumor expression more than 1 percent
5. Adequate performance status (e.g., ECOG performance status of 0-2).
6. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
7. Prior systemic treatment for metastatic NSCLC will be allowed
8. Willingness and ability to undergo stool sample collection for gut microbiome analysis.
9. Patients scheduled to receive immunotherapy as part of their treatment.
10. Adequate organ function (e.g., liver, kidney, hematological parameters) to tolerate immunotherapy.
11. Ability to provide informed consent and comply with study requirements. |
|
| ExclusionCriteria |
| Details |
1. Previous exposure to immunotherapy or other immune checkpoint inhibitors.
2. Presence of other active malignancies or history of recent cancer treatment.
3. History of autoimmune diseases or immunodeficiency disorders.
4. Current use of antibiotics, probiotics, or other medications known to significantly affect the gut microbiome.
5. Severe gastrointestinal disorders or conditions that may impact gut microbiota composition (e.g., inflammatory bowel disease).
6. Inability to provide informed consent or comply with study procedures.
7. Contraindications to undergoing stool sample collection or microbial analysis (e.g., active gastrointestinal bleeding, recent bowel surgery).
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Characterize the composition and diversity of the gut microbiome in NSCLC patients undergoing immunotherapy.
|
18months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the impact of factors such as treatment history, antibiotic and steroid usage, and patient demographics on the gut microbiome and its relationship with clinical outcomes, such as progression-free survival (PFS) and overall survival (OS), in NSCLC patients receiving immunotherapy.
|
18months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Lung cancer is the most commonly diagnosed cancer globally, accounting for approximately 11.4% of all new cancer cases. In India, lung cancer accounts for 5.9% of all cancers and 8.1% of all cancer-related deaths, making it the fourth leading cause of cancer-related incidence and mortality. About 85% of lung cancers are non-small cell lung cancer (NSCLC) and about 15% are small cell lung cancer (SCLC). The human body is home to approximately 40 trillion microbial cells, with the gastrointestinal tract housing the largest number of microbial species known as the gut microbiome. Imbalances in the gut microbiome, known as dysbiosis, have been associated with various diseases, including cancer. Advanced non-small cell lung cancer (NSCLC) is a devastating disease with a grim prognosis and is the leading cause of cancer-related deaths. However, the advent ofimmunotherapy has shown remarkable clinical efficacy in treating advanced NSCLC, surpassing conventional chemotherapy in both second-line and first-line treatments. Recent studies have revealed that the gut microbiota plays a role in mediating diverse responses to immunotherapy and may serve as a potential predictive biomarker. Study demonstrated that the diversity of gut microbiota is linked to a positive response to immunotherapy in patients with NSCLC. Aim of the study: To investigate the association between the gut microbiome and response to immunotherapy in patients with non-small cell lung cancer (NSCLC). Objectives of the study: Characterize the composition and diversity of the gut microbiome in NSCLC patients undergoing immunotherapy and, evaluate the impact of factors such as treatment history, antibiotic and steroid usage, and patient demographics on the gut microbiome and its relationship with clinical outcomes, such as progression-free survival (PFS) and overall survival (OS), in NSCLC patients receiving immunotherapy. Implications of The Study: Understanding the relationship between gut microbiome diversity and treatment outcomes could provide valuable insights for optimizing therapeutic strategies and improving patient responses to immunotherapy. |