Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03897374 |
| Other study ID # |
02252019 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2019 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
ClinLogic LLC |
| Contact |
C David, MBA |
| Phone |
7174671201 |
| Email |
stopcancer[@]callmdglobal.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The primary goal of the study is to record data over the observation period to evaluate the
clinical benefit of using hereditary cancer genomic diagnostics to assess overall hereditary
genetic cancer risk profile and to help guide physicians to pursue preventative measures,
which may lead to early detection and treatment of the condition.
Description:
Data collection will be limited to study subjects 65 years or older. The genes evaluated may
be modified from time to time by the Sponsor as the body of knowledge expands and important
additional pathways are identified. The list of appropriate genes that may be considered by
the treating physician includes but are not necessarily limited to the following genes: ATM,
BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, EPCAM, MLH1, MRE11A, MSH2, MSH6, NBN, PALB2, PMS2,
PTEN, RAD50, RAD51C, RAD51D, RINT1, TP53 and XRCC2. These subjects must also meet medical
necessity for hereditary cancer genomic testing; and allow physician to test based on medical
necessity. Hereditary Cancer testing will be diagnostic rather than screening in nature.
Study subject data will be collected only if medical necessity was established, subject
agreed to test based on medical necessity and hereditary cancer genomic test was ordered by a
physician related to individual study subject care considerations. The hereditary Cancer
testing is independent of this data-collection, non- interventional study. The hereditary
cancer genomic test must be ordered according to the individual study subject care
considerations, it is not protocol specified, and will not be considered as "research" that
is part of the study. Rather, the use of hereditary cancer genomic testing serves as criteria
for eligibility in the study and must have been ordered for medical necessity and results
received no less than 90 days prior before data is collected.
The primary goal of the study is to record data over the observation period to evaluate the
clinical benefit of using hereditary cancer genomic diagnostics to assess overall hereditary
genetic cancer risk profile and to help guide physicians to pursue preventative measures,
which may lead to early detection and treatment of the condition; and to record physician
recommended treatments and subject's brief medical history, demographic data; and
investigator specialty.
Such genetic test results and recommended treatments can be tabulated and analyzed to
demonstrate the clinical utility of using hereditary cancer genomic diagnostics for
prevention, early detection and treatment of the condition.
The data will be collected retrospectively for a total of 120 no more than 150 days over the
observation period in one (1) Case Report Form (survey). Similarly, the secondary objectives
will be tabulated over the same observation period.
An interim analysis of data will be performed to determine if the study subject data
collection should be increased or decreased in order to fulfill study objectives.
