An observational study in Advanced Gastrointestinal Cancers, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-17.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 230 are open to participants now.
This study's planned enrollment of 200 is close to the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Locally advanced or metastatic gastrointestinal cancer (including gastroesophageal, pancreatic, biliary tract and colorectal cancer)
Patients must either:
Patients must either:
Exclusion Criteria:
The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.
Time frame: 18 months
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.
Time frame: 18 months
Response rate for patients who received a targeted treatment as a result of genetic sequencing.
Time frame: 18 months
Overall survival of patients who received targeted treatment.
Time frame: 18 months
Evaluation of any changes in molecular markers at the time of disease progression or response to those from previous specimens.
To examine tumour heterogeneity in patients with paired specimens
Time frame: 18 months
Description of the microRNA expression profile of gastrointestinal tumours
Time frame: 18 months
Evaluation of any changes in circulating tumour DNA at the time of progression or response in comparison to previous specimens
Time frame: 18 months
Duration of response for patients who received a targeted treatment as a result of genetic sequencing.
Time frame: 18 months
This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Royal Marsden NHS Foundation Trust