Esthesioneuroblastoma: Outcomes After Treatment (ENB)

February 8, 2021 updated by: Ricardo L. Carrau, MD
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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with esthesioneuroblastoma (ENB)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 120 months after treatment
Progression-free survival and overall survival
Time Frame: Up to 120 months
Kaplan-Meier survival curves
Up to 120 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ricardo L. Carrau, MD

Investigators

  • Principal Investigator: Ricardo Carrau, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 8, 2021

Study Completion (Actual)

February 8, 2021

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015C0066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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