Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450171
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population the INFORM Study
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population the INFORM Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this research study is to evaluate the possible benefits and harms of screening with an investigational blood test designed to detect many types of cancer early
The name of the screening blood test being studied is
-GRAIL Galleri test
The name of the screening blood test being studied is
-GRAIL Galleri test
Detailed Description:
This is a prospective interventional study to assess the use of the GRAILs Galleri multi-cancer early detection MCED Test an investigational blood test designed to detect many types of cancer for participants that are considered at slightly higher than average risk of developing certain types of cancers The test looks for small pieces of genetic material called deoxyribonucleic acid DNA in the blood that may indicate the presence of cancer
The research study procedures include screening for eligibility blood tests questionnaires and clinic visits
Participation in this research study is expected to last up to 3 years
It is expected that about 1000 people will take part in this research study
The research study procedures include screening for eligibility blood tests questionnaires and clinic visits
Participation in this research study is expected to last up to 3 years
It is expected that about 1000 people will take part in this research 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