Sarcoma,Soft TissueNCT05614375
Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus
An observational study of Sarcoma,Soft Tissue and Nasal Cavity Cancer, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma,Soft Tissue, Nasal Cavity Cancer, Paranasal Sinus Cancer
- What is being tested?
- endoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2021to 12 Jun 2026
- How long will I take part?
- 5 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For patients diagnosed with STS in the nasal cavity and paranasal sinuses through pathology, appropriate subjects will be selected according to the selection criteria and exclusion criteria of the protocol design.
Who may be able to join
- Sign the informed consent form;
- STS of nasal cavity and paranasal sinuses diagnosed pathologically;
- General physical condition can tolerate endoscopic sinus surgery;
- There is no distant transfer;
- The research team must believe that the patient can be completely removed by surgery;
- Good organ function;
Who cannot join
- The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction;
- Suffer from uncontrolled concurrent diseases;
- There is a serious neurological or mental illness, including dementia and epileptic seizures;
- Uncontrolled active infection;
- There are any other circumstances that may hinder the compliance of the research;
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu Hongmeng
Shanghai, Shanghai Municipality, 200031
hongmeng Yu, doctor, 13501730576, hongmengyush@fudan.edu.cn
Kai Xue, doctor
About this study
Official title: Prospective Observational Single Arm Study of Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus
Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. According to different morphologies and biological behaviors, there are more than 50 subtypes. The most common subtypes include: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma ( SS). The most common soft tissue sarcoma in children and adolescents is rhabdomyosarcoma (RMS). Soft tissue sarcoma is a group of highly heterogeneous tumors, which are characterized by local invasiveness, invasive or destructive growth, local recurrence and distant metastasis.
The pathological features of STS that occur in the nasal cavity and sinuses are similar to other parts of the body. However, because it can affect important structures such as the orbit, optic nerve, skull base bone, dura mater, cranial nerve and even brain tissue, the diseased site is deep, the anatomical structure is complex, the treatment is difficult, the range of surgical resection is limited, and the surgical margin Negative is difficult to guarantee, and related treatments may have obvious complications, which affect the survival and prognosis of patients.
Read more
Surgical treatment is the most important and most likely effective treatment for STS. With the development of endoscopic skull base anatomy and surgical techniques, the safety and effectiveness of endoscopic sinus surgery for the treatment of nasal cavity and sinus tumors have been fully confirmed, and it has become the main surgical method for nasal cavity and sinus STS. This is also the theoretical and practical basis for the feasibility of this research.
The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.
Read the detailed description
The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.This study is divided into a screening period, a treatment period, and a follow-up period. All subjects need to sign an informed consent form before screening, perform relevant blood tests, imaging examinations, and compare the inclusion and exclusion criteria to select suitable patients to enter the treatment period. The follow-up period is 5 years.
- Being tested
- endoscopic surgery
- Keywords
- soft tissue sarcoma, nasal cavity and paranasal sinus, endoscopic surgery, prognose, overall survival rate, outcome, quality of life
- Medical subject headings
- Sarcoma, Paranasal Sinus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
transnasal endoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| soft tissue sarcoma with endoscopic surgery | patients with soft tissue sarcoma accept endoscopic surgery Receives: Procedure: endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
From the day of enrollment to death for any reason
Measured: From date of enrollment until the date of death from any cause, whichever came first，through study completion,up to 5 years.
Secondary outcomes (2)
Local recurrence-free survival
The time from enrollment to local recurrence or death for any reason
Measured: From date of first treatment until the date of local recurrence or the date of death from any cause,through study completion,up to 5 years.
quality of life
The Chinese version of EORTC QLQ C30 questionnaire (V3.0)
Measured: within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start12 Jun 2021
- Primary completion12 Jun 2023 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614375
- Sponsor's protocol ID
- SNSTS-SA-01-V1
- Status last verified
- Nov 2022
- First submitted
- 9 Dec 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Single Arm Study of Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus
- ClinicalTrials.gov ID
- NCT05614375
- Acronym / sponsor ID
- SNSTS-SA-01-V1
- Keywords
- soft tissue sarcoma, nasal cavity and paranasal sinus, endoscopic surgery, prognose, overall survival rate, outcome, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 12 Jun 2023 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 14 Nov 2022 (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.
Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. According to different morphologies and biological behaviors, there are more than 50 subtypes. The most common subtypes include: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma ( SS). The most common soft tissue sarcoma in children and adolescents is rhabdomyosarcoma (RMS). Soft tissue sarcoma is a group of highly heterogeneous tumors, which are characterized by local invasiveness, invasive or destructive growth, local recurrence and distant metastasis.
The pathological features of STS that occur in the nasal cavity and sinuses are similar to other parts of the body. However, because it can affect important structures such as the orbit, optic nerve, skull base bone, dura mater, cranial nerve and even brain tissue, the diseased site is deep, the anatomical structure is complex, the treatment is difficult, the range of surgical resection is limited, and the surgical margin Negative is difficult to guarantee, and related treatments may have obvious complications, which affect the survival and prognosis of patients.
Surgical treatment is the most important and most likely effective treatment for STS. With the development of endoscopic skull base anatomy and surgical techniques, the safety and effectiveness of endoscopic sinus surgery for the treatment of nasal cavity and sinus tumors have been fully confirmed, and it has become the main surgical method for nasal cavity and sinus STS. This is also the theoretical and practical basis for the feasibility of this research.
The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.
Detailed description
The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.This study is divided into a screening period, a treatment period, and a follow-up period. All subjects need to sign an informed consent form before screening, perform relevant blood tests, imaging examinations, and compare the inclusion and exclusion criteria to select suitable patients to enter the treatment period. The follow-up period is 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| soft tissue sarcoma with endoscopic surgery | – | Procedure: endoscopic surgerypatients with soft tissue sarcoma accept endoscopic surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For patients diagnosed with STS in the nasal cavity and paranasal sinuses through pathology, appropriate subjects will be selected according to the selection criteria and exclusion criteria of the protocol design.
Key inclusion criteria (6 listed)
- Sign the informed consent form;
- STS of nasal cavity and paranasal sinuses diagnosed pathologically;
- General physical condition can tolerate endoscopic sinus surgery;
- There is no distant transfer;
- The research team must believe that the patient can be completely removed by surgery;
Key exclusion criteria (6 listed)
- The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction;
- Suffer from uncontrolled concurrent diseases;
- There is a serious neurological or mental illness, including dementia and epileptic seizures;
- Uncontrolled active infection;
- There are any other circumstances that may hinder the compliance of the research;
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 |
|---|---|---|
| endoscopic surgerytransnasal endoscopic surgery | Procedure or surgery | soft tissue sarcoma with endoscopic surgery |
Primary outcome
overall survival
Time frame: From date of enrollment until the date of death from any cause, whichever came first，through study completion,up to 5 years.
From the day of enrollment to death for any reason
2 secondary outcomes
Local recurrence-free survival
Time frame: From date of first treatment until the date of local recurrence or the date of death from any cause,through study completion,up to 5 years.
quality of life
Time frame: within 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided. 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.
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 Sarcoma,Soft Tissue and Nasal Cavity Cancer, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From date of enrollment until the date of death from any cause, whichever came first，through study completion,up to 5 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 14 Nov 2022.