Osteosarcoma in Patients Older Than 40 Years. Prognostic Factors and Survival
NCT ID: NCT03911245
Last Updated: 2019-04-11
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
195 participants
OBSERVATIONAL
2018-01-01
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of a Cohort of Cases of Synovial Sarcoma Treated in the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between 1983 and 2016
NCT03833037
An Observational Study of Local Relapse After High Grade Osteosarcoma
NCT06017518
Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour
NCT06524583
Omentectomy vs Omental Preservation in Resectable Cancer
NCT05747482
Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa
NCT03977818
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Describe the prognostic factors of osteosarcoma in patients aged 40 years or older, treated at the Hospital de la Santa Creu and Sant Pau in Barcelona during the years 1986-2016, as well as overall survival and disease-free survival.
* Quantify the frequency of limb salvage surgery and amputation, determining the influence of the use of neoadjuvant chemotherapy in the definitive therapeutic management.
* Compare the results obtained with a group formed patients with a range of less than 40 years, diagnosed and treated with osteosarcoma at the Hospital de la Santa Creu i Sant Pau in Barcelona during the same period of years.
The secondary objectives of this study are the following:
* Analyze the frequency of occurrence of local recurrence.
* Determine postoperative complications.
* Evaluate the frequency of distant spread of the disease.
* Describe the characteristics of the group of patients in the study.
* Demonstrate that the incidence of osteosarcoma in adulthood is increasing over the years.
* Determine predisposing factors or lesions to the appearance of osteosarcoma not described in the literature.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with age equal or older than 40 years
Retrospective study. Analyze of data in medical records
Retrospective study. Analyze of data in medical records
Patients with age less than 40 years
Retrospective study. Analyze of data in medical records
Retrospective study. Analyze of data in medical records
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Retrospective study. Analyze of data in medical records
Retrospective study. Analyze of data in medical records
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age equal to or greater than 40 years.
* Osteosarcoma localized in axial skeleton or limbs, diagnosis confirmed by performing a biopsy of the lesion in the Hospital of Santa Creu i Sant Pau, and subsequent histological analysis by the Pathological Anatomy Service of the same center, or, by histological review of the sample obtained from the biopsy performed in the reference center of patients from other hospitals.
* Age less than 40 years for the first age group.
* Minimum follow-up of 12 months.
Exclusion Criteria
* Age less than 40 years.
* Follow-up less than 12 months.
* Patients who present as a single surgical intervention, and therefore, osteosarcoma was not treated surgically in a definitive manner.
* Patients in whom there is an inconsistency between the histological diagnosis of the biopsy and the resection piece, that is, the diagnosis after the definitive study of the resection piece has not corresponded to the osteosarcoma, although it is outside the histological study of the bone biopsy.
* Patients who have undergone a surgical treatment of their tumor lesion, except in the diagnostic biopsy, in another hospital center.
Second age group (\<40 years):
* Osteosarcomas from other locations (head, neck, thorax and cervical, dorsal or lumbosacral spine).
* Age equal to or greater than 40 years.
* Follow-up less than 12 months.
* Patients subjected to a biopsy as the only surgical intervention, and that therefore, osteosarcoma was not definitively treated surgically.
* Patients in whom there is an incongruence between the histological diagnosis of the biopsy and the resection piece, that is, the diagnosis after the definitive study of the resection piece has not corresponded to that of osteosarcoma, although initially it was after the study Histological examination of the bone biopsy.
* Patients who have undergone a surgical treatment of their tumor lesion, except for the diagnostic biopsy, in another hospital center.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marta Almenara
Role: PRINCIPAL_INVESTIGATOR
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bacci G, Longhi A, Versari M, Mercuri M, Briccoli A, Picci P. Prognostic factors for osteosarcoma of the extremity treated with neoadjuvant chemotherapy: 15-year experience in 789 patients treated at a single institution. Cancer. 2006 Mar 1;106(5):1154-61. doi: 10.1002/cncr.21724.
Joo MW, Shin SH, Kang YK, Kawai A, Kim HS, Asavamongkolkul A, Jeon DG, Kim JD, Niu X, Tsuchiya H, Puri A, Wang EH, Chung SH, Chung YG. Osteosarcoma in Asian Populations Over the Age of 40 Years: A Multicenter Study. Ann Surg Oncol. 2015 Oct;22(11):3557-64. doi: 10.1245/s10434-015-4414-6. Epub 2015 Feb 13.
Longhi A, Errani C, Gonzales-Arabio D, Ferrari C, Mercuri M. Osteosarcoma in patients older than 65 years. J Clin Oncol. 2008 Nov 20;26(33):5368-73. doi: 10.1200/JCO.2007.14.9104. Epub 2008 Sep 22.
Iwata S, Ishii T, Kawai A, Hiruma T, Yonemoto T, Kamoda H, Asano N, Takeyama M. Prognostic factors in elderly osteosarcoma patients: a multi-institutional retrospective study of 86 cases. Ann Surg Oncol. 2014 Jan;21(1):263-8. doi: 10.1245/s10434-013-3210-4. Epub 2013 Aug 23.
Grimer RJ, Cannon SR, Taminiau AM, Bielack S, Kempf-Bielack B, Windhager R, Dominkus M, Saeter G, Bauer H, Meller I, Szendroi M, Folleras G, San-Julian M, van der Eijken J. Osteosarcoma over the age of forty. Eur J Cancer. 2003 Jan;39(2):157-63. doi: 10.1016/s0959-8049(02)00478-1.
Carsi B, Rock MG. Primary osteosarcoma in adults older than 40 years. Clin Orthop Relat Res. 2002 Apr;(397):53-61. doi: 10.1097/00003086-200204000-00008.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIBSP-OST-2017-67
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.