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 26, 2021
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Condition or disease | Intervention/treatment |
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Cancer | Genetic: KRAS-variant and microRNA binding site mutation testing |
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 |

Group/Cohort | Intervention/treatment |
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Family Registry
For individuals identified with the KRAS-variant. Patients will be prospectively followed to determine the impact of lifestyle on disease risk.
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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.
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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.
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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.
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- 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.
- 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.
- 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

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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 |
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

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
Contact: Joanne Weidhaas, MDPhD | 203-671-1308 | joanne@mirakind.org | |
Contact: Joanne Weidhaas | 424-387-8100 | Joanne@miradx.com |
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 |
Principal Investigator: | Joanne Weidhaas, MDPhD | MiraKind |
Publications:
Responsible Party: | MiraKind |
ClinicalTrials.gov Identifier: | NCT02253251 |
Other Study ID Numbers: |
Pro00009633 |
First Posted: | October 1, 2014 Key Record Dates |
Last Update Posted: | August 26, 2021 |
Last Verified: | August 2021 |
Breast Cancer Cancer Risk Family Breast and Ovarian Cancer Genetic Cancer Risk |
Cancer Treatment Familial multiple primary cancer risk Autoimmunity Endometriosis |