ICONIC: Improving Outcomes Through Collaboration in OsteosarComa
NCT ID: NCT04132895
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2019-10-25
2027-01-31
Brief Summary
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The 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.
Blood 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.
Alongside 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.
Ultimately, the aim is to improve the care and treatment of osteosarcoma patients so that they may live longer and better lives.
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Detailed Description
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Generally 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.
Outcome, 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%).
Survival 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.
The 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.
The 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.
There 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.
Osteosarcoma 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:
* patients with widely spread (metastatic) disease;
* patients with tumours in the less common locations such as the pelvis, spine and skull;
* patients with osteosarcoma with a background of skeletal abnormalities or an underlying genetic predisposition;
* the 50% of osteosarcoma arising in patients over 40 years.
Little 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.
Overall, there is a need to broaden the ambition and scope of osteosarcoma research while improving access for all patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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observational only, no interventions are prescribed in protocol.
* Treatment will be given as per usual standard of care.
* No treatments are specified by this protocol.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent of patient and/or parent/legal guardian.
Exclusion Criteria
ALL
No
Sponsors
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Bone Cancer Research Trust
UNKNOWN
University College, London
OTHER
Responsible Party
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Principal Investigators
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Sandra Strauss, MD
Role: PRINCIPAL_INVESTIGATOR
University College Hospitals London
Locations
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University College Hospitals London NHS Foundation Trust
London, Greater London, United Kingdom
NHS Grampian Health Board
Aberdeen, , United Kingdom
Birmingham Women's and Childrens NHS Foundation Trust
Birmingham, , United Kingdom
The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Cardiff and Vale University LHB
Cardiff, , United Kingdom
NHS Lothian Health Board
Edinburgh, , United Kingdom
NHS Greater Glasgow and Clyde Health Board
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Courtney Willis
Role: primary
Suzanne Gatz
Role: primary
Michael Parry
Role: primary
Jenny Sherriff
Role: primary
Han Wong
Role: primary
Cathy Morley-Jacob
Role: primary
Angela Jesudason
Role: primary
Ioanna Nixon
Role: primary
Diana McIntosh
Role: backup
Dan Stark
Role: primary
Simone Wilkins
Role: backup
Sunita Dhir
Role: primary
Colin Thorbinson
Role: primary
Nasim Ali
Role: primary
Bernadette Brennan
Role: primary
Martin McCabe
Role: primary
Kenneth Rankin
Role: primary
Ivo Hennig
Role: primary
Paul Cool
Role: primary
Sarah Pratap
Role: primary
Daniel Yeomanson
Role: primary
Robin Young
Role: primary
Peter Simmonds
Role: primary
Other Identifiers
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UCL/18/0248
Identifier Type: -
Identifier Source: org_study_id
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