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NCT04755855 Clinical Trial

Prospective Sinonasal Cancer Multi-institution Study

Sinonasal Carcinoma Clinical Trial

Official title:
Sinonasal Cancer Study to Evaluate Oncologic Outcomes and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04755855
Other study ID # 20-010181
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 2031

Study information
Verified date August 2023
Source Mayo Clinic
Contact Marissa Larson
Phone (507) 216-4999
Email larson.marissa@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multi-institution prospective study of patients with sinonasal malignancies. The goal of this study is to learn more about the course of sinonasal cancer, treatment outcomes, and patient quality of life. In addition, central mutational and genomic analysis of tumor tissue will be evaluated.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 2031
Est. primary completion date January 2031
Accepts healthy volunteers No
Gender All
Age group 30 Days to 99 Years
Eligibility Inclusion Criteria: - Subjects between the ages of 30 days (non-inclusive) and 99 years (inclusive) - Patients with a diagnosis of sinonasal cancer - Patients undergoing treatment at Mayo Clinic Exclusion Criteria: - Healthy individuals - Unwilling to sign the informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oncologic outcomes as measured by overall survival, disease specific survival and recurrence free survival Through study completion, an average of 5 years
Secondary Quality of life outcomes including the University of Washington Quality of Life Questionnaire (UW-QOL v4) and the Sinonasal Outcome Test 22 (SNOT22) Through study completion, an average of 5 years
Secondary Describe the molecular foundation of sinonasal malignancies utilizing RNA sequencing to identify transcriptomic tumor profiles Through study completion, an average of 5 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05151588 - Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma Phase 2
Completed NCT04788264 - Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment N/A
Active, not recruiting NCT03082534 - Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT01586767 - Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy N/A
Recruiting NCT03942380 - Cell-free Tumor DNA in Head and Neck Cancer Patients N/A
Recruiting NCT04979000 - HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors
No longer available NCT03874455 - Tazemetostat Expanded Access Program for Adults With Solid Tumors

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