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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 : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
MiraKind

Tracking Information
First Submitted Date September 25, 2014
First Posted Date October 1, 2014
Last Update Posted Date September 29, 2017
Study Start Date September 2014
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2014)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02253251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 26, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
Official Title Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples Without DNA
Description:
DNA will be isolated from the submitted sample and kept with permission for additional studies.
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.
Condition Cancer
Intervention Genetic: KRAS-variant and microRNA binding site mutation testing
Participant in these studies will be tested for the KRAS-variant
Study Groups/Cohorts
  • Family Registry
    For individuals identified with the KRAS-variant. Patients will be prospectively followed to determine the impact of lifestyle on disease risk.
    Intervention: Genetic: KRAS-variant and microRNA binding site mutation testing
  • 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.
    Intervention: Genetic: KRAS-variant and microRNA binding site mutation testing
  • 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.
    Intervention: Genetic: KRAS-variant and microRNA binding site mutation testing
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 26, 2014)
15000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Joanne Weidhaas, MDPhD 203-671-1308 joanne@mirakind.org
Contact: Joanne Weidhaas 424-387-8100 Joanne@miradx.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02253251
Other Study ID Numbers Pro00009633
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MiraKind
Study Sponsor MiraKind
Collaborators Not Provided
Investigators
Principal Investigator: Joanne Weidhaas, MDPhD MiraKind
PRS Account MiraKind
Verification Date September 2017