Esthesioneuroblastoma, Olfactory Clinical Trial
— ENBOfficial title:
Esthesioneuroblastoma: Outcomes After Treatment
| NCT number | NCT02580136 |
| Other study ID # | 2015C0066 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | February 8, 2021 |
| Verified date | February 2021 |
| Source | Ohio State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | February 8, 2021 |
| Est. primary completion date | February 8, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Between the age of 10-80 years - Diagnosed with esthesioneuroblastoma Exclusion Criteria: - Refusal to participate |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ricardo L. Carrau, MD |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Progression-free survival and overall survival | Kaplan-Meier survival curves | Up to 120 months | |
| Secondary | Number of participants with intraoperative complications | up to 120 months | ||
| Secondary | Number of participants with postoperative complications | up to 120 months | ||
| Secondary | Length of Hospital Stay | up to 120 months | ||
| Secondary | Time spent in operating room | up to 120 months | ||
| Secondary | MRI imaging evidence of resection | up to 120 months | ||
| Secondary | Surgical Technique | up to 120 months |