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Old 12-04-2014, 02:40 PM   #1
'lizbeth
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Post Role of microRNA Binding Site Mutations in Cancer

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

http://www.clinicaltrials.gov/ct2/sh...variant&rank=1


This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by MiraKind
Sponsor:
MiraKind
Information provided by (Responsible Party):
MiraKind
ClinicalTrials.gov Identifier:
NCT02253251
First received: September 25, 2014
Last updated: September 26, 2014
Last verified: September 2014
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
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 breast cancer.


Condition Intervention
Cancer
Genetic: KRAS-variant

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Breast Cancer Cancer
Genetic and Rare Diseases Information Center resources: Ovarian Cancer
U.S. FDA Resources

Further study details as provided by MiraKind:

Primary Outcome Measures:
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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:
The impact of lifestyle factors on cancer risk for KRAS-variant patients [ Time Frame: 10 years ] [ Designated as safety issue: No ]
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.


Estimated Enrollment: 15000
Study Start Date: September 2014
Estimated Study Completion Date: September 2025
Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Participant in these studies will be tested for the KRAS-variant
Pregnancy Associated Breast Cancer
Women with PABC will be tested for the KRAS-variant, and women with and without this mutation will be compared.
Genetic: KRAS-variant
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
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
Participant in these studies will be tested for the KRAS-variant

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.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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.

Criteria
Inclusion Criteria:

Personal or family history of cancer
Exclusion Criteria:

Younger than 18
Non-english speaking and unable to understand and sign the consent
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02253251

Contacts
Contact: Joanne Weidhaas, MDPhD 203-671-1308 joanne@mirakind.org
Contact: Brigitte Van Essen 650-787-5610 bvanessen@miradx.com

Locations
United States, California
MiraKind Recruiting
Menlo Park, California, United States, 94026
Contact: Joanne Weidhaas, MDPhD 203-671-1308 joanne@mirakind.org
Contact: Brigitte Vanessen 650-787-5610
Sponsors and Collaborators
MiraKind
Investigators
Principal Investigator: Joanne Weidhaas, MDPhD MiraKind
More Information

Additional Information:
non-profit running the study This link exits the ClinicalTrials.gov site

Publications:
Saridaki Z, Weidhaas JB, Lenz HJ, Laurent-Puig P, Jacobs B, De Schutter J, De Roock W, Salzman DW, Zhang W, Yang D, Pilati C, Bouché O, Piessevaux H, Tejpar S. A let-7 microRNA-Binding Site Polymorphism in KRAS Predicts Improved Outcome in Patients with Metastatic Colorectal Cancer Treated with Salvage Cetuximab/Panitumumab Monotherapy. Clin Cancer Res. 2014 Sep 1;20(17):4499-510. doi: 10.1158/1078-0432.CCR-14-0348.
Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Jul 31. pii: mdu367. [Epub ahead of print]
Pilarski R, Patel DA, Weitzel J, McVeigh T, Dorairaj JJ, Heneghan HM, Miller N, Weidhaas JB, Kerin MJ, McKenna M, Wu X, Hildebrandt M, Zelterman D, Sand S, Shulman LP. The KRAS-variant is associated with risk of developing double primary breast and ovarian cancer. PLoS One. 2012;7(5):e37891. doi: 10.1371/journal.pone.0037891. Epub 2012 May 25.
Grechukhina O, Petracco R, Popkhadze S, Massasa E, Paranjape T, Chan E, Flores I, Weidhaas JB, Taylor HS. A polymorphism in a let-7 microRNA binding site of KRAS in women with endometriosis. EMBO Mol Med. 2012 Mar;4(3):206-17. doi: 10.1002/emmm.201100200. Epub 2012 Feb 3.
Ratner ES, Keane FK, Lindner R, Tassi RA, Paranjape T, Glasgow M, Nallur S, Deng Y, Lu L, Steele L, Sand S, Muller RU, Bignotti E, Bellone S, Boeke M, Yao X, Pecorelli S, Ravaggi A, Katsaros D, Zelterman D, Cristea MC, Yu H, Rutherford TJ, Weitzel JN, Neuhausen SL, Schwartz PE, Slack FJ, Santin AD, Weidhaas JB. A KRAS variant is a biomarker of poor outcome, platinum chemotherapy resistance and a potential target for therapy in ovarian cancer. Oncogene. 2012 Oct 18;31(42):4559-66. doi: 10.1038/onc.2011.539. Epub 2011 Dec 5.
Lee LJ, Ratner E, Uduman M, Winter K, Boeke M, Greven KM, King S, Burke TW, Underhill K, Kim H, Boulware RJ, Yu H, Parkash V, Lu L, Gaffney D, Dicker AP, Weidhaas J. The KRAS-variant and miRNA expression in RTOG endometrial cancer clinical trials 9708 and 9905. PLoS One. 2014 Apr 14;9(4):e94167. doi: 10.1371/journal.pone.0094167. eCollection 2014.
Smits KM, Paranjape T, Nallur S, Wouters KA, Weijenberg MP, Schouten LJ, van den Brandt PA, Bosman FT, Weidhaas JB, van Engeland M. A let-7 microRNA SNP in the KRAS 3'UTR is prognostic in early-stage colorectal cancer. Clin Cancer Res. 2011 Dec 15;17(24):7723-31. doi: 10.1158/1078-0432.CCR-11-0990. Epub 2011 Oct 12.
Paranjape T, Heneghan H, Lindner R, Keane FK, Hoffman A, Hollestelle A, Dorairaj J, Geyda K, Pelletier C, Nallur S, Martens JW, Hooning MJ, Kerin M, Zelterman D, Zhu Y, Tuck D, Harris L, Miller N, Slack F, Weidhaas J. A 3'-untranslated region KRAS variant and triple-negative breast cancer: a case-control and genetic analysis. Lancet Oncol. 2011 Apr;12(4):377-86. doi: 10.1016/S1470-2045(11)70044-4. Epub 2011 Mar 22. Erratum in: Lancet Oncol. 2011 Jun;12(6):522.
Hollestelle A, Pelletier C, Hooning M, Crepin E, Schutte M, Look M, Collee JM, Nieuwlaat A, Dorssers LC, Seynaeve C, Aulchenko YS, Martens JW, van den Ouweland AM, Weidhaas JB. Prevalence of the variant allele rs61764370 T>G in the 3'UTR of KRAS among Dutch BRCA1, BRCA2 and non-BRCA1/BRCA2 breast cancer families. Breast Cancer Res Treat. 2011 Jul;128(1):79-84. doi: 10.1007/s10549-010-1080-z. Epub 2010 Jul 30.
Ratner E, Lu L, Boeke M, Barnett R, Nallur S, Chin LJ, Pelletier C, Blitzblau R, Tassi R, Paranjape T, Hui P, Godwin AK, Yu H, Risch H, Rutherford T, Schwartz P, Santin A, Matloff E, Zelterman D, Slack FJ, Weidhaas JB. A KRAS-variant in ovarian cancer acts as a genetic marker of cancer risk. Cancer Res. 2010 Aug 15;70(16):6509-15. doi: 10.1158/0008-5472.CAN-10-0689. Epub 2010 Jul 20.
Chin LJ, Ratner E, Leng S, Zhai R, Nallur S, Babar I, Muller RU, Straka E, Su L, Burki EA, Crowell RE, Patel R, Kulkarni T, Homer R, Zelterman D, Kidd KK, Zhu Y, Christiani DC, Belinsky SA, Slack FJ, Weidhaas JB. A SNP in a let-7 microRNA complementary site in the KRAS 3' untranslated region increases non-small cell lung cancer risk. Cancer Res. 2008 Oct 15;68(20):8535-40. doi: 10.1158/0008-5472.CAN-08-2129.

Responsible Party: MiraKind
ClinicalTrials.gov Identifier: NCT02253251 History of Changes
Other Study ID Numbers: Pro00009633
Study First Received: September 25, 2014
Last Updated: September 26, 2014
Health Authority: United States: Institutional Review Board
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