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

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ClinicalTrials.gov Identifier: NCT02253251
Recruitment Status : Recruiting
First Posted : October 1, 2014
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
MiraKind

Study Description
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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
Cancer 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
Study Start Date : September 2014
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
DNA will be isolated from the submitted sample and kept with permission for additional studies.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253251


Contacts
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Contact: Joanne Weidhaas, MDPhD 203-671-1308 joanne@mirakind.org
Contact: Joanne Weidhaas 424-387-8100 Joanne@miradx.com

Locations
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United States, California
MiraKind Recruiting
Los Angeles, California, United States, 90025
Contact: Joanne Weidhaas, MDPhD    203-671-1308    joanne@mirakind.org   
Contact: Joanne Weidhaas    424-387-8100      
Sponsors and Collaborators
MiraKind
Investigators
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Principal Investigator: Joanne Weidhaas, MDPhD MiraKind
More Information
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Additional Information:

Publications:

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Responsible Party: MiraKind
ClinicalTrials.gov Identifier: NCT02253251    
Other Study ID Numbers: Pro00009633
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by MiraKind:
Breast Cancer
Cancer Risk
Family Breast and Ovarian Cancer
Genetic Cancer Risk
 Cancer Treatment
Familial multiple primary cancer risk
Autoimmunity
Endometriosis