Feasibility of a Molecular Characterisation Approach to Treatment (FOrMAT)

Royal Marsden NHS Foundation Trust

Status: Unknown

Conditions: Advanced Gastrointestinal Cancers

Study type: Observational

Funder types: Other

Identifiers

NCT02112357

CCR 3994

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).

2. Histological or cytological confirmation of diagnosis of malignancy.

3. Patients must either:

   1. Have received at least one line of treatment for locally advanced/metastatic disease OR
   2. Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease

4. 18 years of age and over .

5. Performance status less than or equal to 2.

6. Able to provide fully informed consent.

7. Patients must either:

   1. 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
   2. Have a site of disease which is amendable to biopsy

Exclusion criteria

• There are no specific exclusion criteria for this study.

Trial design

200 participants in 1 patient group

Targeted genetic sequencing of tumour specimen