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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

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ClinicalTrials.gov Identifier: NCT03833037
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment
Soft Tissue Sarcoma Adult Other: Soft tissue sarcomas in adults

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 23 Years
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)
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021



Intervention Details:
  • Other: Soft tissue sarcomas in adults
    Adult sinovial sarcoma


Primary Outcome Measures :
  1. Number of cases of synovial sarcoma [ Time Frame: Two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833037


Contacts
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Contact: Isidro Gracia +34935537032 ext +34935537032 igracia@santpau.cat
Contact: Claudia Lamas +34935537032 ext +34935537031 clamasg@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Isidro Gracia    +34649236737 ext +34649236737    igracia@santpau.cat   
Contact: Claudia Lamas    +34649236737 ext +34649236737    clamasg@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Study Director: Claudia Lamas Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional Information:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03833037     History of Changes
Other Study ID Numbers: IIBSP-SAR-2018-100
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Synovial sarcoma

Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue