| 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
|
|
|
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. |