Soft Tissue Sarcoma AdultNCT03833037
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
An observational study of Soft Tissue Sarcoma Adult, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Soft Tissue Sarcoma Adult
- What is being tested?
- Soft tissue sarcomas in adults
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 31 Dec 2019
- How long will I take part?
- 23 Years
- 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 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma Adult
- Being tested
- Soft tissue sarcomas in adults
- Keywords
- Synovial sarcoma
- Medical subject headings
- Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue sarcomas in adultsOther
Adult sinovial sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of synovial sarcoma
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 102 participants (actual)
- Target duration
- 23 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Lamas, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833037
- Sponsor's protocol ID
- IIBSP-SAR-2018-100
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03833037
- Acronym / sponsor ID
- IIBSP-SAR-2018-100
- Conditions
- Soft Tissue Sarcoma Adult
- Keywords
- Synovial sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 23 Years
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft tissue sarcomas in adultsAdult sinovial sarcoma | Other | – |
Primary outcome
Number of cases of synovial sarcoma
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Lamas study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma Adult, 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 1 inclusion and 0 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 24 Feb 2020. 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?
Number of cases of synovial sarcoma (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2020.