NGS in Gallbladder Cancer and Response to Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorBanaras Hindu University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Next generation sequencing

    Diagnostic test

    NGS is carried out on DNA isolated from paraffin embedded tissue

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Gallbladder Cancer1 intervention

Trial outcomes

Primary outcomes

1

Response to treatment

Response to treatment in terms of chemotherapy

Time frame
1 year
2

Overall Survival

Survival of patients from the date of diagnosis to closure of study or death which ever is earlier

Time frame
5 year

Secondary outcomes

1

PFS

Progression free survival from the date of diagnosis to progression of disease

Time frame
5 yers
2

RFS

Recurrence free Survival from the date of diagnosis to occurrence of recurrence or metastasis

Time frame
5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.