Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03429036
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2018-02-09
Brief Title:
Biospecimen Procurement for Head and Neck Disorders
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biospecimen Procurement for the Study of Head and Neck Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-26
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
Researchers want to learn more about head and neck disorders Understanding these disorders could help them find better treatments To do this they are collecting tissue samples for research
Objective
To create a repository of tissue samples and data to better study conditions of the head and neck
Eligibility
People who had or will have tissue samples taken because of a head or neck disorder They must be ages 3 and older and not pregnant to join Part 2
Design
Participants will be screened with a questionnaire medical history and physical exam
Part 1 Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used
If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue they will be invited to join Part 2
Part 2 Participants will have additional samples collected These could be
Blood Blood is drawn through a needle in the arm
Cheek swab or brushing A cotton swab or small brush is rubbed inside the cheek
Saliva They rinse their mouth with water and spit into a tube or cup
Skin biopsy They are injected with a numbing drug A biopsy tool removes a small piece of skin
Mucosal biopsy They are injected in the mouth with a numbing medication A small piece of tissue from the inside of the cheek is removed
Participants samples will be used for future research including genetic testing
Researchers want to learn more about head and neck disorders Understanding these disorders could help them find better treatments To do this they are collecting tissue samples for research
Objective
To create a repository of tissue samples and data to better study conditions of the head and neck
Eligibility
People who had or will have tissue samples taken because of a head or neck disorder They must be ages 3 and older and not pregnant to join Part 2
Design
Participants will be screened with a questionnaire medical history and physical exam
Part 1 Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used
If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue they will be invited to join Part 2
Part 2 Participants will have additional samples collected These could be
Blood Blood is drawn through a needle in the arm
Cheek swab or brushing A cotton swab or small brush is rubbed inside the cheek
Saliva They rinse their mouth with water and spit into a tube or cup
Skin biopsy They are injected with a numbing drug A biopsy tool removes a small piece of skin
Mucosal biopsy They are injected in the mouth with a numbing medication A small piece of tissue from the inside of the cheek is removed
Participants samples will be used for future research including genetic testing
Detailed Description:
Background
NCI Head and Neck Clinical Research Program HN CRP investigators are studying the natural history and treatment of diverse conditions of the head and neck at the National Institutes of Health NIH These studies require the collection of biospecimens for research purposes
Studies performed may support development of future protocols that include new therapeutic agents novel treatment approaches and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication
Objectives
Primary To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders
Secondary To share specimens for Patient-Derived Xenograft PDX and organoid research as well as analysis of cellular molecular genetic and genomic biology of normal processes and disorders
Eligibility
Participants must be diagnosed with a disorder of the head and neck region
Age 3 years
Design
Up to 1000 participants will be enrolled
Part 1 Participants with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research The participants will be enrolled prior to the surgery or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care Participants will be recruited from surgical protocols at the National Institutes of Health NIH Clinical Center or from other participating sites
Part 2 Participants who have agreed to share surgical waste material may be asked to provide additional blood saliva andor oral swabs In addition oral mucosal or skin biopsies may be obtained from adult participants aged 18 and older
No investigational or experimental therapy will be given as part of this protocol
NCI Head and Neck Clinical Research Program HN CRP investigators are studying the natural history and treatment of diverse conditions of the head and neck at the National Institutes of Health NIH These studies require the collection of biospecimens for research purposes
Studies performed may support development of future protocols that include new therapeutic agents novel treatment approaches and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication
Objectives
Primary To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders
Secondary To share specimens for Patient-Derived Xenograft PDX and organoid research as well as analysis of cellular molecular genetic and genomic biology of normal processes and disorders
Eligibility
Participants must be diagnosed with a disorder of the head and neck region
Age 3 years
Design
Up to 1000 participants will be enrolled
Part 1 Participants with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research The participants will be enrolled prior to the surgery or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care Participants will be recruited from surgical protocols at the National Institutes of Health NIH Clinical Center or from other participating sites
Part 2 Participants who have agreed to share surgical waste material may be asked to provide additional blood saliva andor oral swabs In addition oral mucosal or skin biopsies may be obtained from adult participants aged 18 and older
No investigational or experimental therapy will be given as part of this protocol
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 |
|---|---|---|---|
| 18-DC-0051 | None | None | None |