ICONIC: Improving Outcomes Through Collaboration in OsteosarComa
ICONIC
1 other identifier
observational
300
1 country
22
Brief Summary
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
ExpectedAugust 2, 2024
July 1, 2024
5.3 years
July 2, 2019
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility phase: Patient recruitment.
To establish if a full study can be run, with a recruitment rate of ≥ 5 patients per month when 15 sites are open
One year from study opening.
Main Study: Patient recruitment
Enrolment of at least 300 patients with blood and specimen samples at specified time points.
3 years from study opening.
Secondary Outcomes (7)
Correlation of chemotherapy and radiotherapy to outcome
4 years from registration.
Do tumour margin and response to chemotherapy predict local recurrence in OS?
4 years from registration.
Correlation of tumour heterogeneity and clonal evolution to chemotherapy response and patient outcome.
4 years from registration.
Validation of whole genome sequencing
4 years from registration.
Analysis of circulating biomarkers
4 years from registration.
- +2 more secondary outcomes
Interventions
* Treatment will be given as per usual standard of care. * No treatments are specified by this protocol.
Eligibility Criteria
All patients diagnosed with osteosarcoma in the UK at the time of the Study.
You may qualify if:
- 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.)
- Written informed consent of patient and/or parent/legal guardian.
You may not qualify if:
- Diagnosis more than four months prior to registration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Bone Cancer Research Trustcollaborator
Study Sites (22)
University College Hospitals London NHS Foundation Trust
London, Greater London, NW1 2BU, 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
Biospecimen
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. samples are optional.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Strauss, MD
University College Hospitals London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
October 21, 2019
Study Start
October 25, 2019
Primary Completion
January 31, 2025
Study Completion (Estimated)
January 31, 2027
Last Updated
August 2, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share