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

February 21, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Observational, Descriptive and Retrospective Study of a Cohort of 90 Consecutive Cases of Synovial Sarcoma Treated in the Orthopedic Surgery Unit of the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between the Years 1983 and 2016 ( 35 Years)

The main objectives of this study are the following: to describe the prognostic factors of survival of synovial sarcoma in patients treated by the orthopedic surgery unit oncologic of the orthopedic surgery and traumatology service of the Hospital de Sant Pau during the years 1983-2016.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Another objectives of this Study are:

To analyze exhaustively a series of cases of synovial sarcoma (as an example of classic subtype of soft tissue sarcoma) to analyse the complementary tests performed and their evolution over time.

To analyse the results of surgical treatment and adjuvant therapies in synovial sarcoma and its evolution over time.

To study the prognostic factors dependent on the patient and the applied therapeutics.

To establish a results-based treatment and follow-up algorithm for patients diagnosed with synovial sarcoma.

To describe the epidemiological characteristics of the group of patients in the study.

To evaluate the overall survival and disease-free survival as well as the mortality of the disease.

To assess the rate of local recurrence and remote dissemination of synovial sarcomas in the series.

To demonstrate the influence of neoadjuvant chemotherapy and radiotherapy in the treatment of the tumor.

Conduct a study by age group with respect to the influence on patient survival. To carry out a study by tumor-sized groups with respect to the influence on the survival of the patients.

To carry out a chronological study on the influence of the advances in the treatments on the survival of the patients.

Compare the results obtained with the published literature.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The overall sample size will be 90 cases of synovial sarcoma diagnosed and treated by the unit, considering a sufficient number of cases in the analysis with sufficient potency to respond to the issues raised methodology. Sources of information all clinical records of the patients will be reviewed and a total of 104 elements collected, collecting data in relation to the epidemiology, personal and family history, physical examination, complementary tests of Local and extension diagnosis, time to diagnosis and treatment, pathological diagnosis, surgical technique, adjuvant therapy, complications of treatment, staging, clinical evolution, recurrences and metastases, functional valuation and data of survival and follow-up.

Description

Inclusion Criteria:

The inclusion criteria were: diagnosed cases of synovial sarcoma by the service of pathological anatomy and treated by unit orthopedic surgery oncology, in location of limbs, paravertebral trunk and/or pelvis. We studied the complete medical history of the cases available for the analysis and with a minimum follow-up of 12 months.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cases of synovial sarcoma
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Claudia Lamas, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (ACTUAL)

February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-SAR-2018-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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