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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02253251
Enrollment
15000
Registered
2014-10-01
Start date
2014-09-30
Completion date
2035-09-30
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Breast Cancer, Cancer Risk, Family Breast and Ovarian Cancer, Genetic Cancer Risk, Cancer Treatment, Familial multiple primary cancer risk, Autoimmunity, Endometriosis

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.

Interventions

GENETICKRAS-variant and microRNA binding site mutation testing

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

Sponsors

MiraKind
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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

Design outcomes

Primary

MeasureTime frameDescription
Measuring the prevalence of the KRAS-variant in certain populations Prevalence of the KRAS-variant in BRCA negative breast cancer patients1 yearThe 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.
Comparing the impact of interventions in KRAS-variant versus non-KRAS variant populations1 yearWe 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.

Secondary

MeasureTime frameDescription
The impact of lifestyle factors on cancer risk for KRAS-variant patients10 yearsIndividuals with the KRAS-variant will be prospectively followed, and lifestyle factors will be associated with changes in health, including cancer development. Our goal is to compare baseline characteristics between individuals with the KRAS-variant who do, versus do not, develop cancer, for example.

Countries

United States

Contacts

Primary ContactJoanne Weidhaas, MDPhD
joanne@mirakind.org203-671-1308
Backup ContactJoanne Weidhaas
Joanne@miradx.com424-387-8100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026