Clinical trial NCT02253251: Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
Official title: Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Breast Cancer
Cancer Risk
Family Breast and Ovarian Cancer
Genetic Cancer Risk
Cancer Treatment
Familial multiple primary cancer risk
Autoimmunity
Endometriosis
Lead sponsor: MiraKind
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast and ovarian cancer patients and the family members of those that have the KRAS-variant from primarily the US. Those with Autoimmunity.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measuring the prevalence of the KRAS-variant in certain populations Prevalence of the KRAS-variant in BRCA negative breast cancer patients
timeFrame: 1 year
measure: Comparing the impact of interventions in KRAS-variant versus non-KRAS variant populations
timeFrame: 1 year
Secondary outcomes:
measure: The impact of lifestyle factors on cancer risk for KRAS-variant patients
timeFrame: 10 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: MiraKind
state: California
Study officials:
affiliation: MiraKind
name: Joanne Weidhaas, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
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