Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02112357
Status:
UNKNOWN
Last Update Posted:
2014-04-17
First Post:
2014-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Molecular Characterisation Approach to Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Both fresh frozen tissue and formalin-fixed paraffin-embedded (FFPE) tumour samples will be obtained.\n\nBiopsies may be taken at entry to the study and/or at the time of radiological response assessment. Each patient can have a maximum of 3 research biopsies in this study.\n\nUp to 35 ml of blood will be collected at study entry to provide normal germline DNA and for possible additional biomarker analysis. If the patient has consented to optional blood sample collection, then additional blood samples will also be collected at the time of radiological response assessment to study molecular changes that occur during treatment.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Response rate for patients who received a targeted treatment as a result of genetic sequencing.', 'timeFrame': '18 months'}, {'measure': 'Overall survival of patients who received targeted treatment.', 'timeFrame': '18 months'}, {'measure': 'Evaluation of any changes in molecular markers at the time of disease progression or response to those from previous specimens.', 'timeFrame': '18 months', 'description': 'To examine tumour heterogeneity in patients with paired specimens'}, {'measure': 'Description of the microRNA expression profile of gastrointestinal tumours', 'timeFrame': '18 months'}, {'measure': 'Evaluation of any changes in circulating tumour DNA at the time of progression or response in comparison to previous specimens', 'timeFrame': '18 months'}, {'measure': 'Duration of response for patients who received a targeted treatment as a result of genetic sequencing.', 'timeFrame': '18 months'}], 'primaryOutcomes': [{'measure': 'The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'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.', 'timeFrame': '18 months', 'description': "To assess the potential impact of genetic sequencing results on patients' treatment"}, {'measure': 'Evaluation of the time required to obtain genetic sequencing results to see if genetic sequencing could be practically incorporated into clinical practice.', 'timeFrame': '18 months', 'description': 'To assess whether genetic sequencing results can be obtained within a clinically meaningful timeframe'}, {'measure': 'The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate.', 'timeFrame': '18 months'}, {'measure': 'The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients.', 'timeFrame': '18 months'}, {'measure': '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.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['molecular profiling', 'genetic sequencing', 'personalised medicine', 'gastrointestinal cancer'], 'conditions': ['Advanced Gastrointestinal Cancers']}, 'referencesModule': {'references': [{'pmid': '30150316', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '29361134', 'type': 'DERIVED', 'citation': 'Moorcraft 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Locally advanced or metastatic gastrointestinal cancer (including gastroesophageal, pancreatic, biliary tract and colorectal cancer)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).\n2. Histological or cytological confirmation of diagnosis of malignancy.\n3. Patients must either:\n\n 1. Have received at least one line of treatment for locally advanced/metastatic disease OR\n 2. Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease\n4. 18 years of age and over .\n5. Performance status less than or equal to 2.\n6. Able to provide fully informed consent.\n7. Patients must either:\n\n 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\n 2. Have a site of disease which is amendable to biopsy\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT02112357', 'acronym': 'FOrMAT', 'briefTitle': 'Feasibility of a Molecular Characterisation Approach to Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment', 'orgStudyIdInfo': {'id': 'CCR 3994'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Targeted genetic sequencing of tumour specimen'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM 25PT', 'city': 'London and Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Annie Woodburne, MSc, BSc', 'role': 'CONTACT', 'email': 'annie.woodburne@rmh.nhs.uk', 'phone': '+44 (0)208 661 3807'}, {'name': 'Dr. Naureen Starling, BSc, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Sing Yu Moorcraft, MB BCh, MRCP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Royal Marsden NHS Foundation Trust'}], 'centralContacts': [{'name': 'Dr. Naureen Starling, BSc, MBBS, MRCP', 'role': 'CONTACT', 'email': 'naureen.starling@rmh.nhs.uk', 'phone': '+44 (0)208 661 3156'}, {'name': 'Annie Woodburne, BSc, MSc', 'role': 'CONTACT', 'email': 'annie.woodburne@rmh.nhs.uk', 'phone': '+44 (0)208 661 3807'}], 'overallOfficials': [{'name': 'Dr. Naureen Starling, BSc, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}