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
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Characterize the composition and diversity of the gut microbiome in NSCLC patients undergoing immunotherapy.
概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Those who were willing to participate (via written consent form) in the study.
- •Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- •Age more than 18 years at the time of the study.
- •PD-L1 tumor expression more than 1 percent
- •Adequate performance status (e.g., ECOG performance status of 0-2).
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •Prior systemic treatment for metastatic NSCLC will be allowed
- •Willingness and ability to undergo stool sample collection for gut microbiome analysis.
- •Patients scheduled to receive immunotherapy as part of their treatment.
- •Adequate organ function (e.g., liver, kidney, hematological parameters) to tolerate immunotherapy.
排除标准
- •Previous exposure to immunotherapy or other immune checkpoint inhibitors.
- •Presence of other active malignancies or history of recent cancer treatment.
- •History of autoimmune diseases or immunodeficiency disorders.
- •Current use of antibiotics, probiotics, or other medications known to significantly affect the gut microbiome.
- •Severe gastrointestinal disorders or conditions that may impact gut microbiota composition (e.g., inflammatory bowel disease).
- •Inability to provide informed consent or comply with study procedures.
- •Contraindications to undergoing stool sample collection or microbial analysis (e.g., active gastrointestinal bleeding, recent bowel surgery).
结局指标
主要结局
Characterize the composition and diversity of the gut microbiome in NSCLC patients undergoing immunotherapy.
时间窗: 18months
次要结局
- 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.
研究者
Dr Akhil Kapoor
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)