Clinical Trial: Esthesioneuroblastoma: Outcomes After Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Esthesioneuroblastoma: Outcomes After Treatment

Brief Summary: The purpose of this study is to collect and organize data into a repository to gather relevant information for future research from patients diagnosed with a rare malignant sinonasal cancer called esthesioneuroblastoma (ENB) and are scheduled to undergo endonasal skull base surgery. Data being collected includes surgical data, demographics, disease presentation, MRI, CT, PET imaging, and post-operative assessments including pathology tests. After surgery, the investigators will collect chemotherapy and radiation data. Participants will also complete quality of life questionnaires at their follow-up visits.

Detailed Summary:
Sponsor: Ricardo L. Carrau, MD

Current Primary Outcome:

  • Quality of Life [ Time Frame: up to 120 months after treatment ]
    Anterior Skull Base (ASB); Skull Base Inventory (SBI); Multidimensional Disease Specific Inventory MDS; ASB-Nasal 12; Sino-Nasal Outcome Test (SNOT-20)
  • Progression-free survival and overall survival [ Time Frame: Up to 120 months ]
    Kalpan-Meier survival curves


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with intraoperative complications [ Time Frame: up to 120 months ]
  • Number of participants with postoperative complications [ Time Frame: up to 120 months ]
  • Length of Hospital Stay [ Time Frame: up to 120 months ]
  • Time spent in operating room [ Time Frame: up to 120 months ]
  • MRI imaging evidence of resection [ Time Frame: up to 120 months ]
  • Surgical Technique [ Time Frame: up to 120 months ]


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: September 13, 2015
Date Started: September 2015
Date Completion: September 2026
Last Updated: March 31, 2017
Last Verified: March 2017