Clinical trial · Observational
Feasibility of a Molecular Characterisation Approach to Treatment
FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment
NCT02112357CI-TRIAL-00014290FOrMATunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastrointestinal Cancers | Malignant Digestive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Targeted genetic sequencing of tumour specimen
Primary outcomes (1)
- measure
- The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.
- timeFrame
- 18 months
Secondary outcomes (7)
- measure
- The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.
- timeFrame
- 18 months
- measure
- The proportion of patients in whom genetic sequencing was successfully performed.
- timeFrame
- 18 months
- measure
- The percentage of patients with a currently actionable genetic alteration who received targeted therapy as a result of genetic sequencing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDMansukhani 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. PMID 30150316
- DERIVEDMoorcraft 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. PMID 29361134