NCT04755205 A Natural History Study of Children and Adults With Olfactory Neuroblastoma
| NCT ID | NCT04755205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Olfactory Neuroblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 525 participants |
| Start Date | 2022-06-02 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 525 participants in total. It began in 2022-06-02 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* INCLUSION CRITERIA:. * Subjects with histologically documented olfactory neuroblastoma. * Age \>= 3 years old. * Ability of subject to understand and the willingness to sign a written consent document EXCLUSION CRITERIA: Pregnant women are excluded from this study because of more than minimal risk activities (imaging studies with contrast, biopsies) pertaining to enrollment.
Contact & Investigator
Charalampos Floudas, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT04755205 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 120 Years, studying Olfactory Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04755205 currently recruiting?
Yes, NCT04755205 is actively recruiting participants. Contact the research team at marissa.mallek@nih.gov for enrollment information.
Where is the NCT04755205 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04755205 clinical trial?
NCT04755205 is sponsored by National Cancer Institute (NCI). The principal investigator is Charalampos Floudas, M.D. at National Cancer Institute (NCI). The trial plans to enroll 525 participants.