Feasibility of a Molecular Characterisation Approach to Treatment

Royal Marsden NHS Foundation Trust200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Advanced Gastrointestinal Cancers

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Royal Marsden NHS Foundation Trust

London and Surrey, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.

Time frame: 18 months

Secondary Outcomes

The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.

Time frame: 18 months

The proportion of patients in whom genetic sequencing was successfully performed.

Time frame: 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

Time frame: 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

Time frame: 18 months

The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate.

Time frame: 18 months

The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients.

Time frame: 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.

Central Contacts

Dr. Naureen Starling, BSc, MBBS, MRCP

CONTACT

+44 (0)208 661 3156 naureen.starling@rmh.nhs.uk

Annie Woodburne, BSc, MSc

CONTACT

+44 (0)208 661 3807 annie.woodburne@rmh.nhs.uk

Data from ClinicalTrials.gov

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