Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05746182
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-02-17
Brief Title:
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms
Status:
RECRUITING
Status Verified Date:
2024-05
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:
PanNEN
Brief Summary:
This is a prospective observational multi-center pilot study of germline testing for participants receiving care at University of California participating locations with a new or existing diagnosis of Pancreatic Neuroendocrine Neoplasms PanNEN This protocol is an extension of existing Genetic Testing Station efforts at University of California San Francisco UCSF
Detailed Description:
PRIMARY OBJECTIVE
I To assess the frequency of germline mutations in patients with PanNEN
SECONDARY OBJECTIVES
I To assess the rates of different types of germline mutations in patients PanNEN
II To assess the rates of different types of variants of uncertain significance in patients with PanNEN
III To estimate the rate of completion of genetic testing in patients who are offered prospective germline testing
EXPLORATORY OBJECTIVES
I To examine attitudes of patients who have completed germline testing
II To explore reasons for declining germline testing
III In patients with repeat germline testing compare the frequency of germline alteration between tests
IV Assess the relationship between germline pathogenic variants and somatic mutations in PanNEN
OUTLINE
Potential eligible participants will be identified via chart review and invited to consent to the study Study participants who agree to prospective testing and have not had previous large panel germline testing will watch an informational video about germline testing and be offered testing with University of California San Franciscos UCSF Expanded Hereditary Cancer Panel Study participants who decline germline testing will be asked to answer a one-question Declination Survey Results will be shared with participants and their providers per the standard of practice at each participating study site All participants who decided to receive germline testing will be asked to complete a decision survey
I To assess the frequency of germline mutations in patients with PanNEN
SECONDARY OBJECTIVES
I To assess the rates of different types of germline mutations in patients PanNEN
II To assess the rates of different types of variants of uncertain significance in patients with PanNEN
III To estimate the rate of completion of genetic testing in patients who are offered prospective germline testing
EXPLORATORY OBJECTIVES
I To examine attitudes of patients who have completed germline testing
II To explore reasons for declining germline testing
III In patients with repeat germline testing compare the frequency of germline alteration between tests
IV Assess the relationship between germline pathogenic variants and somatic mutations in PanNEN
OUTLINE
Potential eligible participants will be identified via chart review and invited to consent to the study Study participants who agree to prospective testing and have not had previous large panel germline testing will watch an informational video about germline testing and be offered testing with University of California San Franciscos UCSF Expanded Hereditary Cancer Panel Study participants who decline germline testing will be asked to answer a one-question Declination Survey Results will be shared with participants and their providers per the standard of practice at each participating study site All participants who decided to receive germline testing will be asked to complete a decision survey
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 |
|---|---|---|---|
| NCI-2023-01566 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |