The BIOSCOPE Study: Investigating Gut Microbiome Signatures and Clinical Outcomes Following Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare difference in gut microbiome composition and diversity between responders and non responders and measured using 16S rRNA gene sequencing of fecal samples alpha diversity indices beta diversity analysis and differential abundance of bacterial taxa
研究概览
简要总结
This study investigates how gut bacteria affect treatment response in patients with esophageal squamous cell carcinoma receiving neoadjuvant chemoradiation therapy.Stool samples will be collected before during and after treatment to identify bacterial patterns linked to treatment success and side effects. The goal is to improve outcomes by using gut microbiome insights for more personalized care.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Histologically Confirmed Esophageal Squamous Cell Carcinoma 2 Locally Advanced Disease Staging based on TNM classification AJCC 8th edition via endoscopic ultrasound CT and PET CT scans 3 Planned for Standard Neoadjuvant Chemoradiotherapy Followed by Surgery 4 Age 18-75 Years 5 ECOG Performance Status 0-2 6 Availability of Baseline Stool and Blood Samples Adequate Organ Function.
排除标准
- •1 Prior Treatment for ESCC 2.Distant Metastatic Disease 3 Active Gastrointestinal Disorders Affecting Microbiome 4 Severe Comorbidities 5 Pregnancy or Breastfeeding 6 Psychiatric or Cognitive Impairment.
结局指标
主要结局
To compare difference in gut microbiome composition and diversity between responders and non responders and measured using 16S rRNA gene sequencing of fecal samples alpha diversity indices beta diversity analysis and differential abundance of bacterial taxa
时间窗: 3 to 5 years
次要结局
- Longitudinal Microbiome Changes(Microbiome and Toxicity)
研究者
Jasleen Kaur
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab