| CTRI Number |
CTRI/2025/03/082186 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating Metabolomic and Microbiota Shifts in Hepatocellular Carcinoma Patients During Immunotherapy. |
|
Scientific Title of Study
|
Investigating Metabolomic and Microbiota Shifts in Hepatocellular Carcinoma Patients During Immunotherapy. META GUT HCC study Metabolomics and Gut Microbiota in HCC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Asthana |
| Designation |
Clinical Lead. HPB and Multiorgan Transplant Surgery |
| Affiliation |
Aster CMI Hospital |
| Address |
43-2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
09686976379 |
| Fax |
|
| Email |
drsonal.asthana@asterhospital.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Asthana |
| Designation |
Clinical Lead. HPB and Multiorgan Transplant Surgery |
| Affiliation |
Aster CMI Hospital |
| Address |
43-2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
09686976379 |
| Fax |
|
| Email |
drsonal.asthana@asterhospital.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surinder Kher |
| Designation |
Head Clinical Research |
| Affiliation |
Aster CMI Hospital |
| Address |
43-2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
08043420940 |
| Fax |
|
| Email |
research.aster@asterhospital.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aster CMI Hospital |
| Address |
43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sonal Asthana |
Aster CMI Hospital |
Ground Floor, IIL OPD, room No 5 43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA |
09686976379
drsonal.asthana@asterhospital.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster CMI Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
•Adults greater than or equal to 18 years diagnosed with biopsy proven advanced or unresectable HCC.
•Patients with BCLC stage C or BCLC stage B
•Treatment-naïve for systemic therapy.
•Child Pugh A or B ECOG Lesser than or equal to 2.
•Signed informed consent.
|
|
| ExclusionCriteria |
| Details |
•Prior liver transplant.
•Previous systemic therapy for HCC.
•Significant comorbidities or active infections
•High risk esophageal or gastric varices
•Special populations, minors, pregnant mothers, neonates.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in metabolomic profiles and gut microbiota composition in patients with hepatocellular carcinoma (HCC) (BCLC stage B and C) from baseline to after three cycles of immunotherapy with atezolizumab and bevacizumab. |
At Baseline and after 3 months of immunotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To correlate the changes in metabolomic & microbiota profiles with treatment outcomes, including objective response rate (ORR) & progression-free survival (PFS).
2.To identify specific metabolomic markers & microbial taxa that are predictive of a positive or negative response to immunotherapy.
3.To evaluate whether baseline microbiota & metabolomic signatures can serve as predictive biomarkers for treatment efficacy in HCC patients receiving immunotherapy.
4.To explore the association between gut microbiota diversity & shifts in specific metabolic pathways with patient prognosis & immunotherapy-related outcomes.
|
At Baseline & after 3 months of immunotherapy |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
17/03/2025 |
| 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 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
|
Blood samples for
metabolomic analysis will be collected using a dried blood spot (DBS) card.
Participants will clean their hands thoroughly, and the finger to be pricked
will be sanitized with an alcohol swab. A lancet will be used to prick the
finger, and each drop of blood will be placed on the DBS card, ensuring that at
least 35% of each spot is covered. After drying, the DBS cards will be sealed
in ziplock bags and either shipped at ambient temperature or stored at 4°C for
later processing. In the laboratory, metabolites will be extracted by immersing
the DBS card in a solution of methanol, acetonitrile, and formic acid. The
samples will be vortexed, dried, and resuspended for analysis using Liquid
Chromatography-Mass Spectrometry (LCMS), with each LCMS run lasting
approximately 20 minutes per sample.
Fecal samples will be
collected at baseline and after three cycles of treatment using a sterile
collection kit. Samples will be stored at -80°C until processing. For
microbiota analysis, fecal material will be mixed with phosphate-buffered
saline (PBS) and centrifuged to isolate bacterial cells. DNA will be extracted
from the bacterial cells and analyzed using 16S rRNA gene sequencing to assess
microbial diversity and composition. The sequencing data will identify specific
microbial taxa that may correlate with treatment response or disease
progression. |