| CTRI Number |
CTRI/2026/04/108322 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
12/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying gene activity changes in early and advanced stages of gall bladder cancer |
|
Scientific Title of Study
|
An ambispective comparative study of transcriptomic profiling in early and advanced stages of gallbladder adenocarcinoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shashikant C U Patne |
| Designation |
Dean (Academics) Professor (Pathology) |
| Affiliation |
MPMMCC/HOMI BHABHA CANCER HOSPITAL VARANASI |
| Address |
5th Floor Dean (Academics) Professor (Pathology) MPMMCC
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8935031980 |
| Fax |
|
| Email |
SCUPATNE.TMC@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Parijat Datta |
| Designation |
DM Oncopathology resident |
| Affiliation |
MPMMCC/HOMI BHABHA CANCER HOSPITAL VARANASI |
| Address |
5th Floor flat no 510 Dr Nandlal Housing complex Sundarpur
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8787561969 |
| Fax |
|
| Email |
parijatdatta301289@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shashikant C U Patne |
| Designation |
Dean (Academics) Professor (Pathology) |
| Affiliation |
MPMMCC/HOMI BHABHA CANCER HOSPITAL VARANASI |
| Address |
5th Floor Dean (Academics) Professor (Pathology) MPMMCC
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8935031980 |
| Fax |
|
| Email |
SCUPATNE.TMC@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Research Administration Council (ACTREC) Intramural Fund Sector 22 Kharghar Utsav Chowk CISF Road Navi Mumbai Maharastra 410210 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Research Administration Council ACTREC Intramural Fund |
| Address |
Tata Memorial Centre Research Administration Council (ACTREC) Intramural Fund Sector 22 Kharghar Utsav Chowk CISF Road Navi Mumbai Maharastra 410210 India |
| Type of Sponsor |
Research institution and 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 Shashikant C U Patne |
MPMMCC VARANASI |
3rd Floor Department of Oncopathology MPMMCC Varanasi
Varanasi
UTTAR PRADESH |
08935031980
SCUPATNE.TMC@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECMPMMCVARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for gallbladder adenocarcinoma:
1. In-house resected specimens of treatment-naive gall bladder adenocarcinomas received from Department of Surgical Oncology, MPMMCC Varanasi.
2. Histopathologically diagnosed treatment-naive gallbladder adenocarcinoma samples from patients presented with early stages (n=15) (upto T2 stage) and in advanced stages (n=15) (beyond T2).
3. Formalin fixed paraffin-embedded (FFPE) tissues of gallbladder adenocarcinomas with adequate tumor content will be taken up for transcriptomic analysis. will be taken, those contain adequate tumor tissue, for transcriptomic analysis.
Inclusion criteria for controls :
1. In-house resected specimens of cases with benign gallbladder pathology/ uninvolved gallbladder (including chronic cholecystitis, specimen taken out for pancreatico-duodenectomy specimens, received from Department of Surgical Oncology, MPMMCC Varanasi. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for gallbladder adenocarcinoma:
1. Patients who are treated with Neoadjuvant chemotherapy and/or radiotherapy before operative procedure.
2. FFPE tissues in which tumor tissue is inadequate for NGS testing.
3. Biopsy/resection specimens of gall bladder coming from outside will not be included in this study. (Outside processed blocks)
Exclusion criteria for controls :
1. Histologically diagnosed adenocarcinoma or any other malignancy.
2. Benign cases, that shows areas of necrosis, reaction atypia, dysplasia or atrophied gallbladder mucosa will not be included in this study.
• Biopsy/resection specimens of gall bladder coming from outside will not be included in this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To analyse differential gene expression in early and advanced stages of gallbladder adenocarcinoma and compare them with normal gallbladder (control) tissue.
2) To compare the differential expression of genes in early and advanced stages of gallbladder carcinoma.
3) To correlate cliniopathological parameters [age, sex, histologic grade, type and stage of tumour, outcome, etc.] with the results of transcriptomic profile.
|
Baseline
6 Months
12 Months
18 Months
24 Months- End of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/04/2026 |
| 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="2"
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
|
Gallbladder cancer (GBC) is an aggressive and often fatal disease, especially common in northern India. Most patients are diagnosed at an advanced stage when surgery is not possible, and current treatments offer limited benefit. To improve outcomes, it is important to understand the molecular changes that drive cancer progression. This study aims to identify differential gene expression in early-stage and advanced-stage gallbladder cancer using a method called transcriptome analysis. RNA will be extracted from about 40 tissue samples (including early-stage, advanced-stage, and normal gallbladder tissues) collected from patients at HBCH and MPMMCC, Varanasi, using Next Generation Sequencing (NGS), researchers will map and compare gene expression patterns across these samples. The results are expected to identify key genes and biological pathways involved in the development and spread of gallbladder cancer. This knowledge could help discover new biomarkers for early detection and targets for better treatment, ultimately improving patient care. |