About this trial
Evidence suggests distinct models of molecular and pathologic progression, and a growing body of genetics data points to a heterogeneous collection of underlying mutations in key oncogenes and tumor suppressor genes. Although tumor genetics have been used to tailor individual treatment regimens and guide clinical decision making in other cancers, these principles have not been applied in gallbladder malignancy. Recent clinical trials with targeted therapies seem promising, although the relationships between subsets of patients with positive responses to therapy and tumor genetics remain unexplored.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treatment naïve patients with histologically proven carcinoma of the gallbladder.
Disqualifiers
No histological evidence of malignancy
Pregnant and lactating women
Trial population
Patients with histologically confirmed diagnosis of gallbladder cancer irrespective of stage, being treated with palliative or curative intent with standard of care for that stage of carcinoma of the gallbladder
Trial design
Cohort
Prospective
Treatments tested in this trial
Next generation sequencing
Diagnostic testNGS is carried out on DNA isolated from paraffin embedded tissue
Treatment groups
Trial outcomes
Primary outcomes
Response to treatment
Response to treatment in terms of chemotherapy
Overall Survival
Survival of patients from the date of diagnosis to closure of study or death which ever is earlier
Secondary outcomes
PFS
Progression free survival from the date of diagnosis to progression of disease
RFS
Recurrence free Survival from the date of diagnosis to occurrence of recurrence or metastasis
Sponsors and contacts
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