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

MiraKind

Status: Enrolling

Conditions: Cancer

Treatments: Genetic: KRAS-variant and microRNA binding site mutation testing

Study type: Observational

Funder types: Other

Identifiers

NCT02253251

Pro00009633

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15,000 participants in 4 patient groups

Family Registry

Description:

For individuals identified with the KRAS-variant. Patients will be prospectively followed to determine the impact of lifestyle on disease risk.

Treatment:

Genetic: KRAS-variant and microRNA binding site mutation testing

Double primary breast cancer

Description:

Women with multiple primary breast cancer will be tested for the KRAS-variant and compared between those with this mutation and those without.

Treatment:

Genetic: KRAS-variant and microRNA binding site mutation testing

Autoimmunity

Description:

We have shown that the KRAS-variant and other members of this genetic class of mutations associate with altered immunity, leading to immunosuppression as well as autoimmunity.

Treatment:

Genetic: KRAS-variant and microRNA binding site mutation testing

Cancer patients receiving certain treatments

Description:

We have found that microRNA binding site mutations are predictive biomarkers of outcomes from cancer therapy, including response and toxicity. We will enroll patients to further study and validate these findings.

Treatment:

Genetic: KRAS-variant and microRNA binding site mutation testing