Osteosarcoma in Patients Older Than 40 Years. Prognostic Factors and Survival
- Conditions
- Osteosarcoma
- Interventions
- Other: Retrospective study. Analyze of data in medical records
- Registration Number
- NCT03911245
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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.
- Detailed Description
The main objectives of this study are the following:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with age equal or older than 40 years Retrospective study. Analyze of data in medical records - Patients with age less than 40 years Retrospective study. Analyze of data in medical records -
- Primary Outcome Measures
Name Time Method Survival of osteosarcoma 1 year 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.
Prognostic factors of osteosarcoma 1 year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain