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OsteosarcomaNCT03911245

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

An observational study of Osteosarcoma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteosarcoma
What is being tested?
Retrospective study. Analyze of data in medical records
How many people
195 participants
Where
1 siteSpain
Study dates
1 Jan 2018to 31 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.
  • Minimum follow-up of 12 months. The patients included in the study have met all the inclusion criteria.

Who cannot join

  • 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.
Show all 19Show fewer
  • Second age group (<40 years):
  • 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 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.
  • The patients included in the study have met all the inclusion criteria.
  • Exclusion criteria:
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Barcelona, 08025

Other trials in Spain

About this study

Official title: Our Experience About Limb and Pelvic Osteosarcoma in Patients Older Than 40 Years and Comparative Study With the Age Group < 40 Years. Prognostic Factors, Survival, Amputation Rate and Limb Salvage Surgery After Neoadjuvant Chemotherapy

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.

Read the 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.
Conditions
Osteosarcoma
Being tested
Retrospective study. Analyze of data in medical records
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retrospective study. Analyze of data in medical recordsOther

    Retrospective study. Analyze of data in medical records

Study groups in NCT03911245
Study groupRoleWhat they receive
Patients with age equal or older than 40 yearsNot described
Receives: Other: Retrospective study. Analyze of data in medical records
Patients with age less than 40 yearsNot described
Receives: Other: Retrospective study. Analyze of data in medical records

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03911245
Sponsor's protocol ID
IIBSP-OST-2017-67
Status last verified
Apr 2019
First submitted
3 Mar 2019
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16421923

  • 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.

    PubMed 25676843

  • 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.

    PubMed 18809616

  • 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.

    PubMed 23975321

  • 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.

    PubMed 12509946

  • 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.

    PubMed 11953595

Questions about this trial

What is this clinical trial studying?

An observational study of Osteosarcoma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic factors of osteosarcoma (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911245, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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