Feasibility of a Molecular Characterisation Approach to Treatment

Study Overview
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Brief Summary
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This study will assess the feasibility of sequencing locally advanced/metastatic gastrointestinal cancers in real-time to enable future treatment stratification by molecular characteristics. Targeted next generation sequencing of a panel of genes will be performed on tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a patient is potentially suitable for a targeted therapy.

Official Title
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FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment

Conditions
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Advanced Gastrointestinal Cancers

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers). Histological or cytological confirmation of diagnosis of malignancy. Patients must either: Have received at least one line of treatment for locally advanced/metastatic disease OR Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease 18 years of age and over . Performance status less than or equal to 2. Able to provide fully informed consent. Patients must either: Have an available tumour specimen (FFPE or fresh frozen) from either the primary tumour or a metastasis. Metastatic samples may be from any site with the exception of bone. OR Have a site of disease which is amendable to biopsy Exclusion Criteria: There are no specific exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Targeted genetic sequencing of tumour specimen<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques. |  | 18 months | 
| The proportion of patients in whom genetic sequencing was successfully performed. |  | 18 months | 
| The percentage of patients with a currently actionable genetic alteration who received targeted therapy as a result of genetic sequencing. | To assess the potential impact of genetic sequencing results on patients' treatment | 18 months | 
| Evaluation of the time required to obtain genetic sequencing results to see if genetic sequencing could be practically incorporated into clinical practice. | To assess whether genetic sequencing results can be obtained within a clinically meaningful timeframe | 18 months | 
| The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate. |  | 18 months | 
| The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients. |  | 18 months | 
| The number needed to enroll into the trial to identify one patient with a targetable genetic alteration and the number needed to enroll into the trial to treat one patient with a targeted agent. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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molecular profiling, genetic sequencing, personalised medicine, gastrointestinal cancer