Strategic Targeting for Optimal Prevention of Cancer (STOP-Cancer)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    120000
  • sponsor
    ClinLogic LLC
Updated on 9 February 2022

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.

Details
Condition Early Detection of Cancer
Treatment genetic testing
Clinical Study IdentifierNCT03897374
SponsorClinLogic LLC
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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