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RecruitingObservational

Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment

NCT ID: NCT02253251Sponsor: MiraKindLast updated: 2025-01-23

Summary

The investigators will recruit and enroll individuals that may have the KRAS-variant or other microRNA binding site mutations to join registry studies. The investigators will allow individuals to obtain their results through a physician at the completion of the studies. The investigators current focus is cancer and autoimmunity.

Detailed description

The investigators have identified germ-line microRNA binding site mutations that predict an increased risk of cancer, endometriosis and associated infertility, and unique tumor biology and response to treatment. The goal of this protocol is to further determine the mechanisms of these mutations, such as the KRAS-variant, and their associations with human health, such as cancer. The investigators will collect saliva samples from individual patients who are eligible and choose to enroll in these studies, to test for the KRAS-variant and/or other mutations under study. With specific permission, the investigators will keep excess DNA to further investigate and discover additional similar mutations. The investigators purpose is to have participants answer questionnaires about lifestyle factors in an ongoing manner, to understand the impact of different factors on cancer risk for patients with these mutations.

Arms & interventions

  • GeneticKRAS-variant and microRNA binding site mutation testing

    Participant in these studies will be tested for the KRAS-variant

Outcome measures

Primary

  • Measuring the prevalence of the KRAS-variant in certain populations Prevalence of the KRAS-variant in BRCA negative breast cancer patients

    The Prevalence of the KRAS-variant will be determined in specific populations, such as women with drug resistant endometriosis, or BRCA negative breast cancer. The prevalence will be compared to extensive data on the expected and known prevalence of the KRAS-variant in non-diseased populations. Statistical significance will be determined by Chi-squared analysis.

    Time frame: 1 year

  • Comparing the impact of interventions in KRAS-variant versus non-KRAS variant populations

    We will compare the impact of specific treatment approaches for example in women with the KRAS-variant and double primary breast cancer, versus the interventions used in non-KRAS-variant double primary breast cancer patients.

    Time frame: 1 year

Secondary

  • The impact of lifestyle factors on cancer risk for KRAS-variant patients

    Time frame: 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
Inclusion Criteria: * Personal or family history of cancer * Personal history of endometriosis, or autoimmunity Exclusion Criteria: * Younger than 18 * Non-english speaking and unable to understand and sign the consent

Study locations (1)

MiraKind

Los Angeles, California, 90025

Recruiting
Joanne Weidhaas, MDPhD · Contact
Joanne Weidhaas · Contact

References

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Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment | Cancerify