Actively Recruiting
Prospective Observational Study of Endoscopic Surgery for Soft Tissue Sarcoma in Nasal and Paranasal Sinuses
Led by Eye & ENT Hospital of Fudan University · Updated on 2022-11-14
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Soft tissue sarcoma (STS) includes a diverse group of malignant tumors that arise from various connective tissues like muscle, fat, and blood vessels. This research focuses on STS occurring in the nasal cavity and paranasal sinuses, where treatment is challenging due to complex anatomy and proximity to critical structures. The study aims to explore the effects and complications of endoscopic sinus surgery for this condition and its relationship with chemotherapy and radiotherapy in a prospective, observational design. Participants will undergo transnasal endoscopic surgery as the main treatment, with the study structured into a screening period, a treatment period, and a follow-up period lasting up to five years. During screening, patients will provide informed consent and complete blood tests and imaging to confirm eligibility. The study seeks to evaluate the comprehensive treatment model involving surgery alongside other therapies. Throughout the study, participants will be monitored for overall survival up to five years, local recurrence-free survival, and quality of life within the first year after surgery. Researchers will collect relevant clinical data, imaging, and laboratory tests to assess outcomes and complications. The follow-up period will allow long-term observation of the treatment’s impact and patient health status.
CONDITIONS
Brief Title
Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Pathological diagnosis of soft tissue sarcoma in the nasal cavity or paranasal sinuses
- General physical condition suitable to tolerate endoscopic sinus surgery
- No distant metastasis present
- Surgical team believes complete tumor removal by surgery is possible
- Good organ function
You will not qualify if you...
- Having contraindications to surgery such as severe heart or lung disease or blood clotting problems
- Uncontrolled concurrent diseases
- Serious neurological or mental illnesses including dementia or epilepsy
- Uncontrolled active infections
- Any condition that might prevent compliance with the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with immediate recovery period
Participants undergo transnasal endoscopic surgery to remove soft tissue sarcoma in the nasal cavity or paranasal sinuses and receive immediate post-operative care.
1 surgical visit and several immediate post-operative visits
Duration - Up to 5 years
Participants are followed for 5 years to monitor overall survival, local recurrence, and quality of life after surgery.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Yu Hongmeng
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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