Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04261972
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-02-15
First Post:
2020-01-02
Brief Title:
Cell-free DNA in Hereditary And High-Risk Malignancies
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Early Detection of Cancer in High-risk Patients Through Cell-free DNA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
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:
CHARM
Brief Summary:
The goal of this study is to develop an effective sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes HCS If this new blood test is accurate it could be used to screen patients for cancer and allow for earlier cancer detection The study will also use questionnaires and interviews to understand how patients feel about incorporating these tests into routine medical care and the perceptions of the medical value of test results
Detailed Description:
The objective of this protocol is to develop a method to detect early signs of cancer in previvors people with HCS that do not yet have a cancer diagnosis This will enable prediction of cancer onset so that patients and their doctors can make decisions to treat or prevent the cancers HCS patients will be recruited from across Canada to provide blood samples before and after cancer diagnosis In parallel there will be development of a circulating tumour DNA ctDNA -based test to detect early stage cancer and evaluation on the cost-effectiveness and feasibility of integrating such screening protocols into routine clinical care In concert consultation with patients and health care providers will occur to create recommendations for use within clinical care
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