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CTRI Number  CTRI/2025/09/094632 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A multicentric observational study to see how the starting point of bowel cancer and the cancer’s DNA affect the chances of cancer returning after liver surgery 
Scientific Title of Study   The impact of primary tumour location and molecular profile on recurrence patterns following liver resection for colorectal liver metastases (CRLM): a multicentre cohort study (BIO-CRLM Study) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4920 V 1.0 dated 14.07.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Patkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Department of Surgery, GI disease mangement group, 3rd Floor, Homibhabha Building, Dr E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shraddha Patkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Department of Surgery, GI disease mangement group, 3rd Floor, Homibhabha Building, Dr E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shraddha Patkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Department of Surgery, GI disease mangement group, 3rd Floor, Homibhabha Building, Dr E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra India 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Newcastle University Freeman Hospital Newcastle upon Tyne UK  Freeman Rd, High Heaton, Newcastle upon Tyne NE7 7DN, United Kingdom  
 
Countries of Recruitment     India
United Kingdom
Australia
Canada
Germany  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shraddha Patkar  Tata Memorial Hospital  OPD No 324, Dept of Surgical Oncology, Gastrointestinal Disease Management group, 3rd Floor, Homi Bhabah Building, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA 
9820074818

drshraddhapatkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee -1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C210||Malignant neoplasm of anus, unspecified, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary, (4) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult patients aged 18 years and above at the time of liver surgery with histologically confirmed colorectal adenocarcinoma and liver metastases.
2. Patients who underwent curative-intent liver resection from January 2017 to October 2023.
3.Known molecular profile for at least 1 of the following: KRAS/NRAS, BRAF or MSI. Ideally, KRAS/NRAS and BRAF status will be known for all patients after 2010.
 
 
ExclusionCriteria 
Details  1. Incomplete macroscopic (R2) resection
2.Concomitant unresectable extrahepatic disease
3.Patients who have undergone treatment for extrahepatic disease (e.g. lung ablation or resection)
4. Insufficient data for key variables (unknown primary, lack of follow up data)
5.Non-adenocarcinoma histology
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
impact of primary tumour location and tumour molecular profile on patterns of recurrence and survival following curative-intent liver resection for CRLM  upto 18 months after surgery date 
 
Secondary Outcome  
Outcome  TimePoints 
predictors of isolated liver-only recurrence vs. lung-only recurrence versus disseminated disease  upto 18 months after surgery date 
use of systemic therapy (downstaging or post-resection palliative) varies between patients with different primary tumour sites, and whether the benefit of chemotherapy differs by molecular subtype  upto 18 months after surgery date 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="150" 
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)   06/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Large bowel cancer that has spread to liver called as Colorectal liver metastases (CRLMs) do well with liver sugery (resection). Liver surgery helps these patients live longer, sometimes up to 5 years or more, but unfortunately, the cancer often comes back, in half of these patients, usually within 2 years of surgery. Present study analyses the molecular characteristics and anatomical location of primary tumor in large bowel (right vs left vs rectum). Early findings show that bowel cancers from the right side may behave more aggressively, especially when they carry certain mutations like BRAF. These patients tend to have widespread cancer after surgery. On the other hand, people with left-sided cancers that lack these mutations may have slower-growing disease and better chances of avoiding recurrence.

To explore this further, researchers are reviewing data from many hospitals to see how tumour location and genetics together impact cancer comeback and survival. The goal is to help doctors better predict risk and choose the best treatment plan for each patient—including who will benefit most from surgery or chemotherapy.

 In this study, the coordinating centre will only analyse anonymized data shared by the participating centres. No additional tests or interventions will be performed on patients. Strict confidentiality measures will be in place, ensuring that personal information remains protected and is only accessible to the research team.

The collected data will be securely transferred to the coordinating center through a secure electronic system known as REDCap, where it will be analyzed and used to generate results for publication, contributing to improved surgical strategies for colorectal cancer with liver metastases.

 
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