Clinical trial NCT03833037: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma Adult
Keywords: Synovial sarcoma
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 102
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Number of cases of synovial sarcoma
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Claudia Lamas
role: STUDY_DIRECTOR
References: