A Natural History Study of Children and Adults With Olfactory Neuroblastoma

NCT04755205 | Recruiting

• 2 other identifiers: 21000921-C-0009
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Olfactory neuroblastoma (ONB) is a rare cancer. It grows from tissue in the upper part of the nose cavity, related to the sense of smell and can affect a person s sense of smell. Researchers want to better understand the health problems of people with ONB. This may help them design better treatment and supportive care studies. Objective: To better understand ONB-the course of the disease, tumor characteristics, response to treatments, and management of the treatment. Eligibility: People ages 3 years and older who have ONB. They must enroll in NIH studies #19-C-0016 and #18-DC-0051. Design: Participants will be screened with a medical history and medical record review. Participants do not have to visit NIH. Participants will give a blood sample. They will complete surveys to assess their emotional and physical wellbeing and needs. Leftover tissue from biopsies and surgeries will be collected. Participants will take smell tests. They will smell items and answer questions about them. Participants may take taste tests. They will get plastic taste strips that they will move around their mouth to determine the taste. Participants may have a physical exam. Their performance status may be assessed. Participants may give blood, saliva, urine, and nasal secretion samples. Participants may have computed tomography and/or magnetic resonance imaging scans. Participants may have one or more tumor biopsies. Participants will talk to the research team about the results of their medical record/tests evaluation. The team will recommend how to best manage and treat their disease. Participants may give samples and complete surveys every 12 months. Their medical records will be reviewed every year. They will be monitored for the rest of their life.

Conditions

Olfactory Neuroblastoma; Esthesioneuroblastoma

Keywords

esthesioneuroblastoma; nasal cavity tumor; pediatric onb; adult onb; Natural History

Outcome Measures

Primary Outcomes (1)

• Characterize the natural history of ONB

  To characterize the natural history of ONB including clinical presentation, family history, patterns of disease progression, response to current treatment methods, disease recurrence, and overall survival.

  duration of study

Study Arms (1)

Cohort 1

Subjects with confirmed olfactory neuroblastoma.

Eligibility Criteria

• Age: 3 Years - 120 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 with olfactory neuroblastoma.

You may qualify if:

• Subjects with histologically documented olfactory neuroblastoma.
• Age \>= 3 years old.
• Ability of subject to understand and the willingness to sign a written consent document

You may not qualify if:

• Pregnant women are excluded from this study because of more than minimal risk activities (imaging studies with contrast, biopsies) pertaining to enrollment.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Esthesioneuroblastoma, Olfactory

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; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Charalampos Floudas, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa B Mallek, R.N.

CONTACT

(240) 760-7498; marissa.mallek@nih.gov

Charalampos Floudas, M.D.

CONTACT

(240) 474-1575; charalampos.floudas@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 16, 2021
• Study Start: June 2, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-01-22

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)