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BIOmicrobiome Signature and Clinical Outcomes in Preoperative ESCC (BIOSCOPE)

The BIOSCOPE Study: Investigating Gut Microbiome Signatures and Clinical Outcomes Following Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma - BIOSCOPE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/090558
Enrollment
100
Registered
2025-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K229- Disease of esophagus, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: NIL: NIL Intervention4: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 taxaTimepoint: 3 to 5 years—

Secondary

MeasureTime frame
Longitudinal Microbiome Changes Microbiome and Toxicity Survival Outcomes Progression-Free Survival Overall SurvivalTimepoint: 3 to 5 years—

Countries

India

Contacts

Public ContactJasleen Kaur

Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab

ghuman849@gmail.com9915407057

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026