| CTRI Number |
CTRI/2025/07/090558 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
BIOmicrobiome Signature and Clinical Outcomes in Preoperative ESCC (BIOSCOPE) |
|
Scientific Title of Study
|
The BIOSCOPE Study: Investigating Gut Microbiome Signatures and Clinical Outcomes Following Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma |
| Trial Acronym |
BIOSCOPE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ghumanjas |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasleen Kaur |
| Designation |
Research Scientist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab |
| Address |
Room no 103 A wing first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
NIL
Rupnagar
PUNJAB
140901
India |
| Phone |
9915407057 |
| Fax |
|
| Email |
ghuman849@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jasleen Kaur |
| Designation |
Research Scientist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab |
| Address |
Room no 103 A wing first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
NIL
Rupnagar
PUNJAB
140901
India |
| Phone |
9915407057 |
| Fax |
|
| Email |
ghuman849@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasleen Kaur |
| Designation |
Research Scientist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab |
| Address |
Room no 103 A wing first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
NIL
Rupnagar
PUNJAB
140901
India |
| Phone |
9915407057 |
| Fax |
|
| Email |
ghuman849@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital DR E Borges marg Parel Mumbai 400012 |
| Type of Sponsor |
Other [Govermant 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 Alok K Goel |
Homi Bhabha Cancer Hospital & Research Centre New Chandigarh |
Room no 122 A wing Department of Medical Oncology Main Building Plot no 1 Medicity Mullanpur New Chandigarh Punjab
Rupnagar
PUNJAB |
9899701286
alokdrgoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K229||Disease of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
3 to 5 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Longitudinal Microbiome Changes
Microbiome and Toxicity
Survival Outcomes
Progression-Free Survival
Overall Survival |
3 to 5 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2027 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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. |