Gallstones.
Grant Sanders, Andrew N Kingsnorth
https://pubmed.ncbi.nlm.nih.gov/17690370Actively Recruiting
Age: 18Years - 99Years
All Genders
ID05404347
Genetic Mutations and Response to Treatment in Gallbladder Cancer: A Hospital Based Cohort Study
Led by Banaras Hindu University · Updated on 2024-08-13
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gallbladder carcinoma (GBC) is a common and serious form of biliary tract cancer often linked to chronic inflammation and various environmental and genetic factors. Researchers are exploring the genetic mutations involved in GBC to better understand how these changes influence tumor development and response to treatment. This study investigates the relationship between tumor genetics, identified through next generation sequencing, and how patients with gallbladder cancer respond to therapy, aiming to improve personalized treatment approaches. The study involves analyzing tumor tissue using next generation sequencing (NGS) to identify genetic mutations in patients with confirmed gallbladder cancer. This includes patients treated between 2017 and 2020 with available NGS data, as well as newly diagnosed treatment-naïve patients. The study collects comprehensive clinical data, imaging results, and biopsy samples to correlate genetic findings with treatment response and overall survival. Participants will undergo detailed medical history reviews, physical examinations, and routine diagnostic tests, including CT, MRI, or MRCP scans to assess tumor size and stage. Researchers will monitor treatment response over one year and overall survival over five years, along with progression-free and relapse-free survival. Data will be gathered retrospectively and prospectively, with follow-up efforts to assess long-term outcomes. This observational study aims to provide insights into how genetic profiles relate to treatment effectiveness in gallbladder cancer.
CONDITIONS
Brief Title
NGS in Gallbladder Cancer and Response to Treatment
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Treatment na�EFve patients with histologically proven carcinoma of the gallbladder
- Age between 18 and 99 years
- Any gender
You will not qualify if you...
- No histological evidence of malignancy
- Pregnant and lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 month
Participants undergo diagnostic testing including biopsy and imaging to confirm gallbladder cancer and measure tumor dimensions. Next Generation Sequencing (NGS) is performed on tissue samples to analyze gene mutations.
1 to 2 visits depending on diagnostic procedures
Long-term Monitoring
Duration - Up to 5 years
Participants are observed for response to treatment and overall survival over several years following diagnosis and initial testing.
Follow-up visits as per routine care and study protocol
Trial Site Locations
Total: 1 location
1
Banaras Hindu University
Varanasi, Uttar Pradesh, India, 221005
Actively Recruiting
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Research Team
M
Manoj Pandey, MS, PhD
S
S K Singh, MD, DM
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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