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Trial record 1 of 1 for:    02252019
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Strategic Targeting for Optimal Prevention of Cancer (STOP-Cancer)

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ClinicalTrials.gov Identifier: NCT03897374
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : December 12, 2023
Sponsor:
Collaborator:
MDGlobal
Information provided by (Responsible Party):
ClinLogic LLC

Tracking Information
First Submitted Date March 26, 2019
First Posted Date April 1, 2019
Last Update Posted Date December 12, 2023
Actual Study Start Date March 26, 2019
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Strategic Targeting for Optimal Prevention of Cancer
Official Title Strategic Targeting for Optimal Prevention of Cancer
Brief 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.
Detailed 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 120 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals, ages 65 years or older.
Condition Early Detection of Cancer
Intervention Diagnostic Test: Genetic Testing
Buccal swab
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2019)		 120000
Original Estimated Enrollment
 (submitted: March 28, 2019)		 180000
Estimated Study Completion Date August 1, 2025
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Study subjects may be included in the Clinical Trial if they meet all of the following inclusion criteria:

    • individuals, ages 65 years or older;
    • must have met medical necessity for hereditary cancer genomic testing and allowed the physician to test based on medical necessity;
    • hereditary cancer diagnostic test was ordered by a physician related to individual subject care considerations.
    • study subject has or had cancer
    • study subject has at least one family member with cirrent or past cancer

Exclusion Criteria:

  • Study subjects will be excluded from the study if any of the following criteria apply: • study subject is currently hospitalized or incarcerated;

    • study subject is unable to provide an accurate history due to mental incapacity
    • study subject is currently abusing illicit and/or prescription drugs;
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: C David, MBA 7174671201 stopcancer@callmdglobal.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03897374
Other Study ID Numbers 02252019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party ClinLogic LLC
Original Responsible Party Same as current
Current Study Sponsor ClinLogic LLC
Original Study Sponsor Same as current
Collaborators MDGlobal
Investigators Not Provided
PRS Account ClinLogic LLC
Verification Date December 2023