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

NCT ID: NCT03911245

Last Updated: 2019-04-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Osteosarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with age equal or older than 40 years

Retrospective study. Analyze of data in medical records

Intervention Type OTHER

Retrospective study. Analyze of data in medical records

Patients with age less than 40 years

Retrospective study. Analyze of data in medical records

Intervention Type OTHER

Retrospective study. Analyze of data in medical records

Interventions

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Retrospective study. Analyze of data in medical records

Retrospective study. Analyze of data in medical records

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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):


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Almenara

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 16421923 (View on PubMed)

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.

Reference Type RESULT
PMID: 25676843 (View on PubMed)

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.

Reference Type RESULT
PMID: 18809616 (View on PubMed)

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.

Reference Type RESULT
PMID: 23975321 (View on PubMed)

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.

Reference Type RESULT
PMID: 12509946 (View on PubMed)

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.

Reference Type RESULT
PMID: 11953595 (View on PubMed)

Other Identifiers

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IIBSP-OST-2017-67

Identifier Type: -

Identifier Source: org_study_id

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