Esthesioneuroblastoma: Outcomes After Treatment

NCT02580136 | Withdrawn

• 1 other identifier: 2015C0066
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Esthesioneuroblastoma, Olfactory

Keywords

Esthesioneuroblastoma; Tumor; Skull Base Surgery; Sinonasal Cancer

Outcome Measures

Primary Outcomes (2)

• Quality of Life

  Anterior Skull Base (ASB); Skull Base Inventory (SBI); Multidimensional Disease Specific Inventory MDS; ASB-Nasal 12; Sino-Nasal Outcome Test (SNOT-20)

  up to 120 months after treatment

• Progression-free survival and overall survival

  Kaplan-Meier survival curves

  Up to 120 months

Secondary Outcomes (6)

• Number of participants with intraoperative complications

  up to 120 months

• Number of participants with postoperative complications

  up to 120 months

• Length of Hospital Stay

  up to 120 months

• Time spent in operating room

  up to 120 months

• MRI imaging evidence of resection

  up to 120 months

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with esthesioneuroblastoma (ENB)

You may qualify if:

• Between the age of 10-80 years
• Diagnosed with esthesioneuroblastoma

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• Ricardo L. Carrau, MD: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Esthesioneuroblastoma, Olfactory; Neoplasms

Condition Hierarchy (Ancestors)

Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Ricardo Carrau, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 120 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ricardo L. Carrau, MD

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: October 20, 2015
• Study Start: September 1, 2015
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

US (1)