Strategic Targeting for Optimal Prevention of Cancer (STOP-Cancer)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03897374|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment|
|Early Detection of Cancer||Diagnostic Test: Genetic Testing|
Data collection will be limited to study subjects 18 years or older who have received a hereditary cancer genomic diagnostic test results no more than 90 days prior to consent. 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120000 participants|
|Target Follow-Up Duration:||120 Days|
|Official Title:||Strategic Targeting for Optimal Prevention of Cancer|
|Actual Study Start Date :||March 26, 2019|
|Estimated Primary Completion Date :||April 1, 2024|
|Estimated Study Completion Date :||August 1, 2024|
- Diagnostic Test: Genetic Testing
- Genomic cancer screen [ Time Frame: 120 Days ]A study subject is known to have personal and/or family history of cancer known to be influenced by genetic variation.
- Genomic cancer screen [ Time Frame: 120 Days ]A genotype known to be a predisposition for cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897374
|Contact: Diana Messir||239-908-0412||Diana@integritycro.com|
|United States, Kansas|
|PRN of Kansas||Recruiting|
|Wichita, Kansas, United States, 67205|
|Contact: Brianna Newport, CRC email@example.com|
|United States, Pennsylvania|
|York, Pennsylvania, United States, 17403|
|Contact: Marvin Inscore 717-467-1201 firstname.lastname@example.org|