Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-29 @ 3:45 AM
Study NCT ID:
NCT04132895
Status:
RECRUITING
Last Update Posted:
2024-08-02
First Post:
2019-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICONIC: Improving Outcomes Through Collaboration in OsteosarComa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Formalin Fixed Paraffin Embedded (FFPE) archival blocks of tumour tissue removed during routine biopsy or surgery; Whole Blood Samples; New biopsies (FFPE \\& fresh frozen) obtained at relapse, or on resection of local recurrence/metastases.\n\nsamples are optional.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility phase: Patient recruitment.', 'timeFrame': 'One year from study opening.', 'description': 'To establish if a full study can be run, with a recruitment rate of ≥ 5 patients per month when 15 sites are open'}, {'measure': 'Main Study: Patient recruitment', 'timeFrame': '3 years from study opening.', 'description': 'Enrolment of at least 300 patients with blood and specimen samples at specified time points.'}], 'secondaryOutcomes': [{'measure': 'Correlation of chemotherapy and radiotherapy to outcome', 'timeFrame': '4 years from registration.', 'description': 'Correlation of chemotherapy and radiotherapy to outcome.'}, {'measure': 'Do tumour margin and response to chemotherapy predict local recurrence in OS?', 'timeFrame': '4 years from registration.', 'description': 'To use longitudinal data collected in the trial to predict local recurrence.'}, {'measure': 'Correlation of tumour heterogeneity and clonal evolution to chemotherapy response and patient outcome.', 'timeFrame': '4 years from registration.', 'description': 'Use of oncogenomic data collected in the trial to identify potential stratification for various regimens.'}, {'measure': 'Validation of whole genome sequencing', 'timeFrame': '4 years from registration.', 'description': 'Correlation of results from FFPE samples with whole genome sequencing results to identify potential stratification for various regimens.'}, {'measure': 'Analysis of circulating biomarkers', 'timeFrame': '4 years from registration.', 'description': 'Identification of potential tumour biomarkers for Osteosarcoma to predict burden of disease, response to therapy and outcome.'}, {'measure': 'Patient reported outcomes', 'timeFrame': '4 years from registration.', 'description': 'Assessment of the validity of the Sarcoma Assessment Measure (SAM) in osteosarcoma patients.'}, {'measure': 'Analysis of PMBCs for IO research', 'timeFrame': '4 years from registration.', 'description': 'Collection of Peripheral blood mononuclear cells in a cohort of patients for IO research'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteosarcoma', 'Biobank', 'Genomics', 'Tumour markers', 'ImmuneOncology'], 'conditions': ['Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'There has been little improvement in outcome for patients with osteosarcoma (OS) over the last 20 years. There have been only a few clinical trials of new treatments and no major new therapies introduced recently. This is in part because there is no good understanding of the biology of osteosarcoma, but also trials have only included subgroups of patients. The more that is understood about how and why osteosarcoma arises and grows the better clinicians will be able to decide what treatments are most likely to work best.\n\nThe purpose of this project is to collect high quality clinical data about patients of all ages with osteosarcoma, such as information about the size of the disease, how it was diagnosed and where it is at diagnosis, what treatments were given and how the disease responded the treatments.\n\nBlood and tissue samples will also be collected for analysis in research laboratories. By looking at the results of the laboratory findings and the clinical data together, the questions will start to be answered about why osteosarcomas arise and grow, what makes it spread, and why some patients respond to treatment better than others. As time goes on, this information is planned to be used to develop clinical trials of new treatments.\n\nAlongside this, the aim is to find out more about how osteosarcoma and its treatments affect the lives of those living with this disease. This information will help provide the most appropriate care and support that will meet the needs of each patient.\n\nUltimately, the aim is to improve the care and treatment of osteosarcoma patients so that they may live longer and better lives.', 'detailedDescription': 'Osteosarcoma is the most common bone sarcoma, accounting for approximately 30% of all bone sarcoma diagnoses. In England, it accounts for approximately 130 cases per year across all ages.\n\nGenerally osteosarcoma has an early peak in adolescent patients, with a second peak in patients over 60 years of age. There are differing treatments, including chemotherapy with more than one drug and surgery to the primary site - and for metastases where these occur.\n\nOutcome, however, has improved little over the past 25 years with the proportion of patients surviving to 5 years remaining at about 42% for all ages and stages in the UK. Patients under 40 years of age (52%) are more likely to survive for 5 years than patients over 40 years (25%).\n\nSurvival also depends on the primary site of the osteosarcoma. It is poor for patients with tumours that are not in the limbs, at 36% for patients under the age of 40 years and as low as 6% for patients over 40 years. Also patients with metastatic disease at diagnosis still have a poor outcome.\n\nThe use of chemotherapy and surgery depends on factors such as age, the site of the osteosarcoma, how far spread it is and how well the patient is generally, with approximately two thirds of patients currently receiving chemotherapy, radiotherapy and surgery in England each year.\n\nThe most recent randomised trial for osteosarcoma, EURAMOS-1 \\[A randomized trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy\\], was an excellent example of an international effort to seek improved treatments for a rare cancer. Despite the participation of over 2000 patients, there were no changes to the standard of care for osteosarcoma.\n\nThere is still an unmet need to find new approaches, including biomarkers and new, targeted patient specific therapeutic approaches to improve outcomes for this group. This includes searching for improved systemic treatments and better approaches to management of the osteosarcoma. The ICONIC Study will provide a dataset for translational research into osteosarcoma.\n\nOsteosarcoma clinical trials to date have focussed on a limited number of outcomes, usually in the younger patients with a tumour in a limb. So addressing complex inter-related questions has not been possible and several subpopulations of patients have not been studied. This limits opportunities to improve the standard of care. These groups include:\n\n* patients with widely spread (metastatic) disease;\n* patients with tumours in the less common locations such as the pelvis, spine and skull;\n* patients with osteosarcoma with a background of skeletal abnormalities or an underlying genetic predisposition;\n* the 50% of osteosarcoma arising in patients over 40 years.\n\nLittle is currently known about factors influencing treatment decisions in these groups and how consistently a standard of care is applied. The effect of treatments on quality of life, patient reported outcomes and other performance assessments is also not well described or understood. As osteosarcoma is quite rare it can be difficult for General Practitioners (GPs) to identify symptoms and patients often wait a long time before tests for osteosarcoma are carried out. How this affects outcomes is not known.\n\nOverall, there is a need to broaden the ambition and scope of osteosarcoma research while improving access for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with osteosarcoma in the UK at the time of the Study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New histological diagnosis of osteosarcoma or in the absence of osteoid seen on biopsy, pathology and imaging supportive of a diagnosis of osteosarcoma. (It is well recognised that some patients may present with features suggestive of osteosarcoma (under 40 years, radiological abnormality compatible) but in whom no osteoid is detected in needle biopsy. Although categorised as spindle cell tumour of bone, such patients are usually treated in an identical approach to osteosarcoma. A definite diagnosis of osteosarcoma is then often possible after surgery when the entire resection specimen is available.)\n* Written informed consent of patient and/or parent/legal guardian.\n\nExclusion Criteria:\n\n• Diagnosis more than four months prior to registration.'}, 'identificationModule': {'nctId': 'NCT04132895', 'acronym': 'ICONIC', 'briefTitle': 'ICONIC: Improving Outcomes Through Collaboration in OsteosarComa', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'ICONIC: Improving Outcomes Through Collaboration in OsteosarComa', 'orgStudyIdInfo': {'id': 'UCL/18/0248'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational only, no interventions are prescribed in protocol.', 'type': 'OTHER', 'description': '* Treatment will be given as per usual standard of care.\n* No treatments are specified by this protocol.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2BU', 'city': 'London', 'state': 'Greater London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'The Chief Investigator', 'role': 'CONTACT', 'email': 'ctc.iconic@ucl.ac.uk'}], 'facility': 'University College Hospitals London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Aberdeen', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Courtney Willis', 'role': 'CONTACT'}], 'facility': 'NHS Grampian Health Board', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Suzanne Gatz', 'role': 'CONTACT'}], 'facility': "Birmingham Women's and Childrens NHS Foundation Trust", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michael Parry', 'role': 'CONTACT'}], 'facility': 'The Royal Orthopaedic Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jenny Sherriff', 'role': 'CONTACT'}], 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Han Wong', 'role': 'CONTACT'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Cathy Morley-Jacob', 'role': 'CONTACT'}], 'facility': 'Cardiff and Vale University LHB', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Edinburgh', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Angela Jesudason', 'role': 'CONTACT'}], 'facility': 'NHS Lothian Health Board', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ioanna Nixon', 'role': 'CONTACT'}, {'name': 'Diana McIntosh', 'role': 'CONTACT'}], 'facility': 'NHS Greater Glasgow and Clyde Health Board', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dan Stark', 'role': 'CONTACT'}, {'name': 'Simone Wilkins', 'role': 'CONTACT'}], 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Leicester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sunita Dhir', 'role': 'CONTACT'}], 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Colin Thorbinson', 'role': 'CONTACT'}], 'facility': "Alder Hey Children's NHS Foundation Trust", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nasim Ali', 'role': 'CONTACT'}], 'facility': 'The Clatterbridge Cancer Centre NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Bernadette Brennan', 'role': 'CONTACT'}], 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Martin McCabe', 'role': 'CONTACT'}], 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Kenneth Rankin', 'role': 'CONTACT'}], 'facility': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ivo Hennig', 'role': 'CONTACT'}], 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Oswestry', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Paul Cool', 'role': 'CONTACT'}], 'facility': 'The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}, {'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sarah Pratap', 'role': 'CONTACT'}], 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Sheffield', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Daniel Yeomanson', 'role': 'CONTACT'}], 'facility': "Sheffield Children's NHS Foundation Trust", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Sheffield', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Robin Young', 'role': 'CONTACT'}], 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Peter Simmonds', 'role': 'CONTACT'}], 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'centralContacts': [{'name': 'Krystyna Reczko', 'role': 'CONTACT', 'email': 'ctc.iconic@ucl.ac.uk', 'phone': '020 7679 9878'}, {'name': 'Rubina Begum', 'role': 'CONTACT', 'email': 'ctc.iconic@ucl.ac.uk', 'phone': '020 7679 9514'}], 'overallOfficials': [{'name': 'Sandra Strauss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Hospitals London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bone Cancer Research Trust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}