Feasibility of a Molecular Characterisation Approach to Treatment

• Conditions: Advanced Gastrointestinal Cancers

• Registration Number: NCT02112357
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-31
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.	18 months

Secondary Outcome Measures

Name	Time	Method
The proportion of patients in whom genetic sequencing was successfully performed.	18 months
The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients.	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 percentage of patients with a currently actionable genetic alteration who received targeted therapy as a result of genetic sequencing.	18 months	To assess the potential impact of genetic sequencing results on patients' treatment
The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.	18 months
Evaluation of the time required to obtain genetic sequencing results to see if genetic sequencing could be practically incorporated into clinical practice.	18 months	To assess whether genetic sequencing results can be obtained within a clinically meaningful timeframe
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

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 London and Surrey, United Kingdom