Esthesioneuroblastoma, OlfactoryENBNCT02580136
Esthesioneuroblastoma: Outcomes After Treatment
An observational study of Esthesioneuroblastoma, Olfactory, run by Ricardo L. Carrau, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Esthesioneuroblastoma, Olfactory
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 8 Feb 2021
- How long will I take part?
- 120 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with esthesioneuroblastoma (ENB)
Who may be able to join
- Between the age of 10-80 years
- Diagnosed with esthesioneuroblastoma
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Esthesioneuroblastoma, Olfactory, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 120 months after treatment
Progression-free survival and overall survival
Kaplan-Meier survival curves
Measured: Up to 120 months
Secondary outcomes (6)
Number of participants with intraoperative complications
Measured: up to 120 months
Number of participants with postoperative complications
Measured: up to 120 months
Length of Hospital Stay
Measured: up to 120 months
Time spent in operating room
Measured: up to 120 months
MRI imaging evidence of resection
Measured: up to 120 months
Surgical Technique
Measured: up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthesioneuroblastoma, OlfactoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 120 Months
Sponsor and investigators
- Lead sponsor
- Ricardo L. Carrau, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo L. Carrau, MD, Ohio State University
- Investigators
- Ricardo Carrau, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580136
- Sponsor's protocol ID
- 2015C0066
- Acronym
- ENB
- Status last verified
- Feb 2021
- First submitted
- 13 Sep 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthesioneuroblastoma: Outcomes After Treatment
- ClinicalTrials.gov ID
- NCT02580136
- Acronym / sponsor ID
- ENB / 2015C0066
- Conditions
- Esthesioneuroblastoma, Olfactory
- Keywords
- Esthesioneuroblastoma, Tumor, Skull Base Surgery, Sinonasal Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ricardo L. Carrau, MDUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 120 Months
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with esthesioneuroblastoma (ENB)
Key inclusion criteria (2 listed)
- Between the age of 10-80 years
- Diagnosed with esthesioneuroblastoma
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
Kaplan-Meier survival curves
6 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Carrau, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esthesioneuroblastoma, Olfactory, run by Ricardo L. Carrau, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: up to 120 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.