Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755205
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-02-13
Brief Title:
A Natural History Study of Children and Adults With Olfactory Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Natural History Study of Children and Adults With Olfactory Neuroblastoma
Status:
RECRUITING
Status Verified Date:
2024-09-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 recordtests 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
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 andor 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 recordtests 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
Detailed Description:
Background
Olfactory neuroblastoma ONB also known as esthesioneuroblastoma is a malignant tumor of the nasal cavity believed to arise from the olfactory epithelium ONB is rare with a reported incidence of 04 per million approximately 300 cases per year in the United States
ONB most frequently arises in adults aged 20-60 years Pediatric ONB is particularly rare with only small case series or multi-institutional studies reported However a Surveillance Epidemiology and End Results SEER study of 47 pediatric patients with intranasal malignancy reported ONB as the most frequent pediatric intranasal malignancy 28
Due to the location of ONB in the sinonasal tract and anterior skull base the presenting symptoms are often non-specific including nasal obstruction and epistaxis thus patients often present at advanced stages Furthermore ONB has a propensity for local invasion and relatively high rates of distant spread most commonly to the neck lungs and bones
Clinical management in adults is generally surgical with adjuvant radiation
The natural history of pediatric and adult ONB is incompletely understood and treatment options for recurrent or metastatic ONB are limited The planned natural history study as part of the NCI POB Rare Tumor Patient Engagement Network RTPEN will allow for comprehensive evaluation and recommendations to these patients while longitudinally collecting clinical epidemiologic and biological data
Objective
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
Eligibility
Participants of age 3 years old with histologically documented ONB
Subjects must also enroll on NIDCD Protocol 18-DC-0051
Design
This protocol is intended to characterize the natural history of olfactory neuroblastoma
Participants will undergo a comprehensive study entry evaluation including acquisition of imaging of tumor sites
Medical histories will be documented and participants followed throughout the course of their disease with particular attention to patterns of disease recurrence and progression response to therapies duration of responses and patient reported outcomes Specimens will be obtained longitudinally when feasible and tumor growth rates will also be assessed throughout the course of the disease when feasible
Blood and tumor samples may be obtained at study entry and while on study
Olfactory neuroblastoma ONB also known as esthesioneuroblastoma is a malignant tumor of the nasal cavity believed to arise from the olfactory epithelium ONB is rare with a reported incidence of 04 per million approximately 300 cases per year in the United States
ONB most frequently arises in adults aged 20-60 years Pediatric ONB is particularly rare with only small case series or multi-institutional studies reported However a Surveillance Epidemiology and End Results SEER study of 47 pediatric patients with intranasal malignancy reported ONB as the most frequent pediatric intranasal malignancy 28
Due to the location of ONB in the sinonasal tract and anterior skull base the presenting symptoms are often non-specific including nasal obstruction and epistaxis thus patients often present at advanced stages Furthermore ONB has a propensity for local invasion and relatively high rates of distant spread most commonly to the neck lungs and bones
Clinical management in adults is generally surgical with adjuvant radiation
The natural history of pediatric and adult ONB is incompletely understood and treatment options for recurrent or metastatic ONB are limited The planned natural history study as part of the NCI POB Rare Tumor Patient Engagement Network RTPEN will allow for comprehensive evaluation and recommendations to these patients while longitudinally collecting clinical epidemiologic and biological data
Objective
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
Eligibility
Participants of age 3 years old with histologically documented ONB
Subjects must also enroll on NIDCD Protocol 18-DC-0051
Design
This protocol is intended to characterize the natural history of olfactory neuroblastoma
Participants will undergo a comprehensive study entry evaluation including acquisition of imaging of tumor sites
Medical histories will be documented and participants followed throughout the course of their disease with particular attention to patterns of disease recurrence and progression response to therapies duration of responses and patient reported outcomes Specimens will be obtained longitudinally when feasible and tumor growth rates will also be assessed throughout the course of the disease when feasible
Blood and tumor samples may be obtained at study entry and while on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-C-0009 | None | None | None |