| CTRI Number |
CTRI/2026/01/100572 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Next Generation Sequencing Study |
|
Scientific Title of Study
|
Next-Generation Sequencing via Tissue and Liquid Biopsy in Patients with Metastatic Pancreatic, Biliary, and Colorectal Cancers: Correlation with Therapeutic Response |
| Trial Acronym |
NGS study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alok K Goel |
| Designation |
Professor and OIC Department of Medical Oncology |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab |
| Address |
Room no 122 A wing first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
NIL
Rupnagar
PUNJAB
140901
India |
| Phone |
9899701286 |
| Fax |
|
| Email |
alokdrgoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok K Goel |
| Designation |
Professor and OIC Department of Medical Oncology |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab |
| Address |
Room no 122 A wing first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
NIL
Rupnagar
PUNJAB
140901
India |
| Phone |
9899701286 |
| Fax |
|
| Email |
alokdrgoel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok K Goel |
| Designation |
Professor and OIC Department of Medical Oncology |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab |
| Address |
Room no 122 A wing first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
NIL
Rupnagar
PUNJAB
140901
India |
| Phone |
9899701286 |
| Fax |
|
| Email |
alokdrgoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital & Research Centre Punjab |
| NIL |
|
|
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
|
| Name |
Address |
| ICMR |
Indian Council of Medical Research (ICMR) Headquarters is V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India |
|
|
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 first floor Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab
Rupnagar
PUNJAB |
09899701286
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: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Histologically confirmed metastatic pancreatic, biliary, or colorectal cancer
Planned systemic therapy
Availability of archival or newly obtained tumor tissue
Willingness to undergo serial blood draws
ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
Written informed consent provided
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Inability to comply with study procedures. Individual who, in opinion of the investigator, may not be able to adhere to the required study protocol or follow-up schedule will excluded.
Presence of a concurrent active malignancy requiring systemic therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Objective Response Rate (ORR)
Definition: Proportion of patients achieving either complete response (CR) or partial response (PR) as assessed by RECIST v1.1 criteria on serial imaging.
|
First response assessment at ~8 weeks after treatment initiation, then every 8–12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Progression-Free Survival (PFS)
|
Time from initiation of systemic therapy to documented radiologic or clinical disease progression or death from any cause.
Based on RECIST v1.1 & clinical judgment |
Concordance Rate Between Tissue and Liquid Biopsy NGS
The proportion of overlapping mutations (e.g., KRAS, TP53, BRAF) identified in both tissue and ctDNA samples at baseline, using Cohen’s kappa to assess agreement.
|
At baseline Before treatment |
Overall Survival (OS)
|
Time from initiation of systemic therapy to death from any cause.
|
| ctDNA Response |
Every 2–3 treatment cycles (~6–8 weeks). |
| Molecular Progression via ctDNA |
During follow-up blood draws every 2 cycles |
Resistance Mutation Detection
Definition: Identification of known resistance mutations |
till progression |
|
|
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)
|
01/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pancreatic and Biliary tract and colorectal cancers represents a group of gastrointestinal malignancies with distinct etiologies but share common challenges in metastatic settings limited treatment options and modest survival outcomes and last stage diagnosis and Pancreatic Ductal Adenocarcinoma and Biliary tract cancers typically present at advanced stage with median overall survival rarely exceeding 12 months even with combination of chemotherapy regime then in this study we want to learn about genetic changes in patients with these type of cancers and we will do it by analysing samples from tumour tissue and blood samples using methods called Next Generation Sequencing and This research may help us to understand how certain gene changes affect how will patients respond to the cancer treatments and Purpose of the studies to find out certain genetic changes in cancers patients can predict how well they will respond to the and see if simple blood test mean liquid biopsy gives similar results to a tissue biopsy Furthermore to check if regular blood test during treatment can help us to see the cancer is responding and if it is becoming resistant to the treatment |