Feasibility of a Molecular Characterisation Approach to Treatment

Advanced Gastrointestinal Cancers Clinical Trial

— FOrMAT  

Official title:

FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02112357
• Other study ID #: CCR 3994
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2014
• Last updated: April 16, 2014
• Start date: February 2014

Study information

• Verified date: April 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr. Naureen Starling, BSc, MBBS, MRCP
• Phone: +44 (0)208 661 3156
• Email: naureen.starling[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: England: Sponsor- The Royal Marsden NHS Foundation TrustEngland: Ethics Committee NRES Committee London - Stanmore
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Gastrointestinal Cancers
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London and Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response rate for patients who received a targeted treatment as a result of genetic sequencing.		18 months	No
Other	Overall survival of patients who received targeted treatment.		18 months	No
Other	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	18 months	No
Other	Description of the microRNA expression profile of gastrointestinal tumours		18 months	No
Other	Evaluation of any changes in circulating tumour DNA at the time of progression or response in comparison to previous specimens		18 months	No
Other	Duration of response for patients who received a targeted treatment as a result of genetic sequencing.		18 months	No
Primary	The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.		18 months	No
Secondary	The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.		18 months	No
Secondary	The proportion of patients in whom genetic sequencing was successfully performed.		18 months	No
Secondary	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	18 months	No
Secondary	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	18 months	No
Secondary	The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate.		18 months	No
Secondary	The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients.		18 months	No
Secondary	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	No