Advanced Gastrointestinal Cancers
Conditions
Keywords
molecular profiling, genetic sequencing, personalised medicine, gastrointestinal cancer
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.
Interventions
None listed
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing. | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients in whom genetic sequencing was successfully performed. | 18 months | — |
| The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques. | 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 |
| 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 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of any changes in molecular markers at the time of disease progression or response to those from previous specimens. | 18 months | To examine tumour heterogeneity in patients with paired specimens |
| Description of the microRNA expression profile of gastrointestinal tumours | 18 months | — |
| Evaluation of any changes in circulating tumour DNA at the time of progression or response in comparison to previous specimens | 18 months | — |
| Duration of response for patients who received a targeted treatment as a result of genetic sequencing. | 18 months | — |
| Overall survival of patients who received targeted treatment. | 18 months | — |
| Response rate for patients who received a targeted treatment as a result of genetic sequencing. | 18 months | — |
Countries
United Kingdom
Contacts
Primary ContactDr. Naureen Starling, BSc, MBBS, MRCP
Backup ContactAnnie Woodburne, BSc, MSc
Outcome results
None listed