Advanced Gastrointestinal CancersFOrMATNCT02112357
Feasibility of a Molecular Characterisation Approach to Treatment
An observational study of Advanced Gastrointestinal Cancers, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Cancers
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced or metastatic gastrointestinal cancer (including gastroesophageal, pancreatic, biliary tract and colorectal cancer)
Who may be able to join
- Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).
- Histological or cytological confirmation of diagnosis of malignancy.
- Patients must either:
- Have received at least one line of treatment for locally advanced/metastatic disease OR
- Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease
- 18 years of age and over .
Show all 11Show fewer
- Performance status less than or equal to 2.
- Able to provide fully informed consent.
- Patients must either:
- 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
- Have a site of disease which is amendable to biopsy
Who cannot join
- There are no specific exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London and Surrey, SM 25PT
Annie Woodburne, MSc, BSc, +44 (0)208 661 3807, annie.woodburne@rmh.nhs.uk
Dr. Naureen Starling, BSc, MBBS, MRCP
About this study
Official title: FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment
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.
- Conditions
- Advanced Gastrointestinal Cancers
- Keywords
- molecular profiling, genetic sequencing, personalised medicine, gastrointestinal cancer
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Targeted genetic sequencing of tumour specimen | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.
Measured: 18 months
Secondary outcomes (7)
The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.
Measured: 18 months
The proportion of patients in whom genetic sequencing was successfully performed.
Measured: 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
Measured: 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
Measured: 18 months
The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate.
Measured: 18 months
The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Naureen Starling, BSc, MBBS, MRCP, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112357
- Sponsor's protocol ID
- CCR 3994
- Acronym
- FOrMAT
- Status last verified
- Apr 2014
- First submitted
- 31 Mar 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mansukhani S, Barber LJ, Kleftogiannis D, Moorcraft SY, Davidson M, Woolston A, Proszek PZ, Griffiths B, Fenwick K, Herman B, Matthews N, O'Leary B, Hulkki S, Gonzalez De Castro D, Patel A, Wotherspoon A, Okachi A, Rana I, Begum R, Davies MN, Powles T, von Loga K, Hubank M, Turner N, Watkins D, Chau I, Cunningham D, Lise S, Starling N, Gerlinger M. Ultra-Sensitive Mutation Detection and Genome-Wide DNA Copy Number Reconstruction by Error-Corrected Circulating Tumor DNA Sequencing. Clin Chem. 2018 Nov;64(11):1626-1635. doi: 10.1373/clinchem.2018.289629. Epub 2018 Aug 27.
PubMed 30150316Moorcraft SY, Gonzalez de Castro D, Cunningham D, Jones T, Walker BA, Peckitt C, Yuan LC, Frampton M, Begum R, Eltahir Z, Wotherspoon A, Teixeira Mendes LS, Hulkki Wilson S, Gillbanks A, Baratelli C, Fotiadis N, Patel A, Braconi C, Valeri N, Gerlinger M, Rao S, Watkins D, Chau I, Starling N. Investigating the feasibility of tumour molecular profiling in gastrointestinal malignancies in routine clinical practice. Ann Oncol. 2018 Jan 1;29(1):230-236. doi: 10.1093/annonc/mdx631.
PubMed 29361134
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment
- ClinicalTrials.gov ID
- NCT02112357
- Acronym / sponsor ID
- FOrMAT / CCR 3994
- Conditions
- Advanced Gastrointestinal Cancers
- Keywords
- molecular profiling, genetic sequencing, personalised medicine, gastrointestinal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted genetic sequencing of tumour specimen | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or metastatic gastrointestinal cancer (including gastroesophageal, pancreatic, biliary tract and colorectal cancer)
Key inclusion criteria (11 listed)
- Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).
- Histological or cytological confirmation of diagnosis of malignancy.
- Patients must either:
- 18 years of age and over .
- Performance status less than or equal to 2.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.
Time frame: 18 months
7 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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Derived from this study: PubMed 30150316Mansukhani S, Barber LJ, Kleftogiannis D, Moorcraft SY, Davidson M, Woolston A, Proszek PZ, Griffiths B, Fenwick K, Herman B, Matthews N, O'Leary B, Hulkki S, Gonzalez De Castro D, Patel A, Wotherspoon A, Okachi A, Rana I, Begum R, Davies MN, Powles T, von Loga K, Hubank M, Turner N, Watkins D, Chau I, Cunningham D, Lise S, Starling N, Gerlinger M. Ultra-Sensitive Mutation Detection and Genome-Wide DNA Copy Number Reconstruction by Error-Corrected Circulating Tumor DNA Sequencing. Clin Chem. 2018 Nov;64(11):1626-1635. doi: 10.1373/clinchem.2018.289629. Epub 2018 Aug 27.
- Derived from this study: PubMed 29361134Moorcraft SY, Gonzalez de Castro D, Cunningham D, Jones T, Walker BA, Peckitt C, Yuan LC, Frampton M, Begum R, Eltahir Z, Wotherspoon A, Teixeira Mendes LS, Hulkki Wilson S, Gillbanks A, Baratelli C, Fotiadis N, Patel A, Braconi C, Valeri N, Gerlinger M, Rao S, Watkins D, Chau I, Starling N. Investigating the feasibility of tumour molecular profiling in gastrointestinal malignancies in routine clinical practice. Ann Oncol. 2018 Jan 1;29(1):230-236. doi: 10.1093/annonc/mdx631.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Naureen Starling, BSc, MBBS, MRCP principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Gastrointestinal Cancers, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Naureen Starling, BSc, MBBS, MRCP (+44 (0)208 661 3156, naureen.starling@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.