[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06773897":3,"trial-entities:NCT06773897":96,"trial-summary:NCT06773897":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":24,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":61,"locations":64,"central_contacts":80,"overall_officials":85,"references":88,"see_also_links":89},"NCT06773897","Pro2023001275","Rutgers University Study of the Genetics of Breast Cancer.","The Rutgers University Genetics Coordinating Center Breast Cancer Study","RECRUITING","2028-04-30","2026-05","2026-05-22","2024-04-15","Rutgers, The State University of New Jersey","OTHER",false,"The goal of this observational study is to learn more about how genes impact the risk of breast cancer. Anyone 18 or older living in the US is eligible, and a diagnosis of cancer is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.","This is an online research study to learn more about how genes affect the risk of breast cancer. No office visit is required and in return, participants may receive information about their genetic ancestry for free. BRCA1 and BRCA2 explain only about 25% of the genetic cause of breast cancer. This study will increase our understanding of the genetic basis of breast cancer, which is a crucial step in drug development to improve current treatment options. The study investigators seek a diverse population because men can also get breast cancer and diversity among participants maximizes the usefulness of the data. Participants will use our online study portal to answer questions about their health and provide their DNA via a saliva sample using a pre-paid mailer. Participation takes approximately 20 minutes. Participants will be invited to share data from their electronic health records, but this is not required for study participation. The study investigators keep participants engaged with short monthly newsletters.",[19,20,21],"Breast Cancer Risk","Breast Cancer Prevention","Breast Cancer",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},25000,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34},"GENETIC","Saliva sample","Saliva sample is sent via prepaid US Mail for DNA extraction",[35,36],"Breast Cancer Cases","Breast Cancer Controls",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Health Surveys","Health surveys are filled out online in the study portal.",[35,36],[42],{"measure":43,"description":44,"timeFrame":45},"Genetic risk variants associated with breast cancer","Genetic factors will be measured through whole exome sequencing along with genotyping of common variants, and then correlated with breast cancer and breast cancer subtype.","2 years",[],"ALL","18 Years",true,{"inclusion":51,"exclusion":59,"raw_text":60},[52,53,54,55,56,57,58],"age 18 years or older","currently living in the United States","able to understand and follow written instructions in English","have access to the internet and a computer, laptop, tablet or smart phone","willing to provide written informed consent for participation","willing to provide DNA via a saliva sample using a collection kit mailed to the study participant's home","willing to complete a survey with questions about health related to the study of breast cancer.",[],"Inclusion Criteria:\n\n* age 18 years or older\n* currently living in the United States\n* able to understand and follow written instructions in English\n* have access to the internet and a computer, laptop, tablet or smart phone\n* willing to provide written informed consent for participation\n* willing to provide DNA via a saliva sample using a collection kit mailed to the study participant's home\n* willing to complete a survey with questions about health related to the study of breast cancer.\n\nExclusion Criteria:\n\n* Not able to meet or fulfill any of the inclusion criteria",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"Rutgers University","Piscataway","New Jersey","08854","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Tara Matise, Ph.D.","CONTACT","848-445-3125","rugcc@rutgers.edu",{"lat":78,"lon":79},40.49927,-74.39904,[81,82],{"name":73,"role":74,"phone":75,"email":76},{"name":83,"role":74,"phone":84,"email":76},"Steve Buyske, Ph.D.","848-445-7680",[86],{"name":73,"affiliation":13,"role":87},"PRINCIPAL_INVESTIGATOR",[],[90,93],{"label":91,"url":92},"Study website with detailed information about the study.","https:\u002F\u002Frugcc.rutgers.edu\u002Fbreast_cancer\u002F",{"label":94,"url":95},"Study portal for participant enrollment and study engagement.","https:\u002F\u002Fgo.rutgers.edu\u002FBCStudyCTG",{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Breast Carcinoma",[],{"nct_id":4,"found":49,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an observational study aiming to enroll 25,000 participants. It is not specified if it is randomized or blinded.","completed","Rutgers University Study of Breast Cancer Genetics","This study from Rutgers University is looking for 25,000 people to help understand how genes affect breast cancer risk. You can join if you are 18 or older, live in the U.S., and can follow instructions in English online. You don't need to have had cancer to participate. The study involves providing a saliva sample (for DNA) and answering health surveys online. Researchers will look for genetic risk variants (changes in genes that might increase risk) linked to breast cancer over two years. The goal is to improve our understanding of breast cancer's genetic causes, which can help with developing new treatments. As a thank you, you can choose to receive information about your genetic ancestry for free.","The primary endpoint, genetic risk variants, will be measured at 2 years.",118,"You will complete health surveys online and provide a saliva sample using a kit mailed to your home. This takes about 20 minutes.","Not stated in the trial record.",[32,38],"v2"]