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Protocol Details

A Natural History Study of Children and Adults with Olfactory Neuroblastoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

21-C-0009

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Olfactory Neuroblastoma;
esthesioneuroblastoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

- Subjects must also enroll on NCI Protocol 18-DC-0051: "Biospecimen Procurement for NIDCD Clinical Protocols".

- 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Charalampos Floudas, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 7N240A
10 CENTER DR
BETHESDA MD 20892
(240) 858-3032
charalampos.floudas@nih.gov

Marissa B. Mallek, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 760-7498
marissa.mallek@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04755205

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