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

Sponsor
MiraKind (Other)
Overall Status
Recruiting
CT.gov ID
NCT02253251
Collaborator
(none)
15,000
1
132
113.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: KRAS-variant and microRNA binding site mutation testing

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
15000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Family Registry

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

Genetic: KRAS-variant and microRNA binding site mutation testing
Participant in these studies will be tested for the KRAS-variant

KRAS-variant BRCA negative Breast Cancer

Women with breast cancer who are BRCA negative will be tested for the KRAS-variant, to determine the associations as well as the prevalence.

Genetic: KRAS-variant and microRNA binding site mutation testing
Participant in these studies will be tested for the KRAS-variant

Double primary breast cancer

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

Genetic: KRAS-variant and microRNA binding site mutation testing
Participant in these studies will be tested for the KRAS-variant

Autoimmunity

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.

Outcome Measures

Primary Outcome Measures

  1. Measuring the prevalence of the KRAS-variant in certain populations Prevalence of the KRAS-variant in BRCA negative breast cancer patients [1 year]

    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.

  2. Comparing the impact of interventions in KRAS-variant versus non-KRAS variant populations [1 year]

    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.

Secondary Outcome Measures

  1. The impact of lifestyle factors on cancer risk for KRAS-variant patients [10 years]

    Individuals 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MiraKind Los Angeles California United States 90025

Sponsors and Collaborators

  • MiraKind

Investigators

  • Principal Investigator: Joanne Weidhaas, MDPhD, MiraKind

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
MiraKind
ClinicalTrials.gov Identifier:
NCT02253251
Other Study ID Numbers:
  • Pro00009633
First Posted:
Oct 1, 2014
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021

Study Results

No Results Posted as of Aug 26, 2021