Osteosarcoma in Patients Older Than 40 Years. Prognostic Factors and Survival

NCT03911245 | Completed

• 1 other identifier: IIBSP-OST-2017-67
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this work is to carry out an exhaustive analysis of the characteristics of osteosarcoma in patients with an age equal to or greater than 40 years, in the Hospital de la Santa Creu and Sant Pau in Barcelona, during the years 1986-2016, with the objective to establish the factors that determine the disease and survival, as well as to evaluate the rates of limb salvage and amputation after neodyuvant chemotherapy. With the result of the results, the report of osteosarcoma and the age less than 40 years, with the aim of providing new information that is related to the appearance of osteosarcoma is available from 40 years.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• Prognostic factors of osteosarcoma

  The impact of prognostic factors was assessed using the log-rank test in univariate analysis. Multivariate analysis was undertaken using the Cox proportional hazards method, with variables chosen using logistic regression with a backward stepwise approach. Relative risks were calculated using the Cox proportional hazards model with only the noted covariate in the model. A p value \<0.05 was considered significant. Confidence intervals of 95 % were calculated for statistical parameters. Statistical analysis was performed using SPSS 24.0 for Windows.

  1 year

• Survival of osteosarcoma

  Overall survival (OS) was defined as the period from date of diagnosis to date of death or last follow-up, and was calculated using Kaplan-Meier survival curves.

  1 year

Study Arms (2)

Patients with age equal or older than 40 years

Other: Retrospective study. Analyze of data in medical records

Patients with age less than 40 years

Other: Retrospective study. Analyze of data in medical records

Interventions

Retrospective study. Analyze of data in medical records OTHER

Retrospective study. Analyze of data in medical records

Patients with age equal or older than 40 years; Patients with age less than 40 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with osteosarcoma located in the extremities or pelvis. Number of subjects over 40 years: 37 patients. Number of subjects under 40 years old: 100 patients.

You may qualify if:

• 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 from the biopsy performed in the reference center of patients from other hospitals.
• Age equal to or greater than 40 years.

You may not qualify if:

• Osteosarcomas from other locations (head, neck, thorax and cervical, dorsal or lumbosacral spine).
• 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):
• 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.
• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (6)

• 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.

  PMID: 16421923 RESULT

• 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.

  PMID: 25676843 RESULT

• 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.

  PMID: 18809616 RESULT

• 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.

  PMID: 23975321 RESULT

• 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.

  PMID: 12509946 RESULT

• 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.

  PMID: 11953595 RESULT

MeSH Terms

Conditions

Osteosarcoma

Interventions

Medical Records

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marta Almenara

  Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: April 11, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)