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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
Sponsor:
Information provided by (Responsible Party):
ClinLogic LLC

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.

Condition or disease Intervention/treatment
Early Detection of Cancer Diagnostic Test: Genetic Testing

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120000 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Intervention Details:
  • Diagnostic Test: Genetic Testing
    Buccal swab


Primary Outcome Measures :
  1. 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.

  2. Genomic cancer screen [ Time Frame: 120 Days ]
    A genotype known to be a predisposition for cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals, ages 18 years or older.
Criteria

Inclusion Criteria:

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

    • individuals, ages 18 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.
    • hereditary cancer diagnostic test was received no more than 90 days prior to data collection.

one or more of the following must be present:

  • study subject has more than one cancer; or
  • study subject has multiple close family members with a cancer diagnosis under the age of fifty; or
  • study subject has three or more close family members with different types of cancer; or
  • study subject has had family that has previously had cancer genetics testing and mutations were identified.

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's medical and medication history is unavailable over the 90-days preceding and following data collection;
    • study subject is unable to provide an accurate history due to mental incapacity
    • study subject is currently abusing illicit and/or prescription drugs;
    • study subject is known to have undergone prior hereditary cancer diagnostic testing for genes specific to the targeted genes, exclusive of the CGx test relating to the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Diana Messir 239-908-0412 Diana@integritycro.com

Locations
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United States, Kansas
PRN of Kansas Recruiting
Wichita, Kansas, United States, 67205
Contact: Brianna Newport, CRC       bnewport@prnofkansas.com   
United States, Pennsylvania
MD@Home Recruiting
York, Pennsylvania, United States, 17403
Contact: Marvin Inscore    717-467-1201    marvinscore@mdathome.com   
Sponsors and Collaborators
ClinLogic LLC

Additional Information:

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Responsible Party: ClinLogic LLC
ClinicalTrials.gov Identifier: NCT03897374     History of Changes
Other Study ID Numbers: 02252019
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No