A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
PREDICT
PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients
1 other identifier
observational
200
1 country
18
Brief Summary
This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
March 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 21, 2027
July 8, 2026
July 1, 2026
1.6 years
January 26, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
• The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52
Assess the Change in Sinonasal outcome test-22(SNOT-22) at 52 weeks post-operatively \[SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally\]
week0-52
• The observed and change from baseline of Modified Lund-Kennedy (MLK) score at week-52
Assess the opacification of the paranasal sinuses by using Modified Lund-Kennedy (MLK) score at week 52. \[MLK score: score 0-24, 24 means worse outcome\]
week0-52
Secondary Outcomes (30)
Changes from baseline at each collection point: • VAS - Total sinus symptoms item
week0-52
Changes in NPS from baseline at each collection point
week0-52
Changes from baseline at each collection point: • VAS - Nasal blockage item
week0-52
Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score
week0-52
Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score
week0-52
- +25 more secondary outcomes
Study Arms (1)
Standard of Care Endoscopic Sinus Surgery (ESS)
Although this study is non-interventional and observational in nature regarding treatment decisions, it is registered as an interventional study focusing on the Standard-of-Care (SoC) Functional Endoscopic Sinus Surgery (FESS) as the index procedure. The "intervention" serves as the baseline event for the prospective evaluation of real-world outcomes. The study aims to assess the clinical trajectory (including SNOT-22, Nasal Polyp Score, and CT findings) following this standard clinical procedure over a 52-week period. The surgery is performed strictly according to clinical routine, local guidelines, and the investigator's professional discretion.
Interventions
This is a standard of care surgical procedure performed according to clinical routine. No experimental treatment or investigational drug is administered as part of this study.
Eligibility Criteria
Chinese CRSwNP Patients
You may qualify if:
- Participant must be 16 years of age or older, at the time of signing the informed consent.
- Participants with a documented diagnosis of CRSwNP.
- Endoscopic nasal polypectomy is performed during the screening period.
- Voluntarily participate and sign the informed consent form as described in A 3.
- No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.
You may not qualify if:
- Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study.
- Currently participating in an interventional study.
- Patients who are unable to independently complete questionnaires due to language barriers or mental status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Changchun, 130033, China
Research Site
Changsha, China
Research Site
Chengdu, 610078, China
Research Site
Guangzhou, 510062, China
Research Site
Guangzhou, 514700, China
Research Site
Guangzhou, China
Research Site
Haikou, 570311, China
Research Site
Kunming, China
Research Site
Nanchang, China
Research Site
Nanjing, China
Research Site
Nanning, 530021, China
Research Site
Qingdao, China
Research Site
Shanghai, 200031, China
Research Site
Shenzhen, China
Research Site
Ürümqi, 830054, China
Research Site
Wuhan, 430000, China
Research Site
Wuhan, China
Research Site
Xiamen, 361003, China
Biospecimen
No Retention of biospecimen.
Study Officials
- PRINCIPAL INVESTIGATOR
Weiping Wen, Professor
First Affiliated Hospital, Sun Yat-Sen University
- PRINCIPAL INVESTIGATOR
Dongdong Zhu, Professor
China-Japan Union Hospital, Jilin University
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2026
First Posted
March 3, 2026
Study Start
March 19, 2026
Primary Completion (Estimated)
October 21, 2027
Study Completion (Estimated)
October 21, 2027
Last Updated
July 8, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.