[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04804878":3,"trial-entities:NCT04804878":85,"trial-summary:NCT04804878":89},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":75,"overall_officials":79,"references":83,"see_also_links":84},"NCT04804878","841718","Morehouse Total Cancer Care Protocol","Morehouse Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer","RECRUITING","2037-04","2021-03","2021-03-18","2018-04-05","Morehouse School of Medicine","OTHER",true,"The overall objective of the Morehouse Total Cancer Care study is to develop an improved standard of cancer care by facilitating new biomarker and drug target discovery, informatics solutions, clinical trials, and \"personalized medicine\" for our community oncology partners (i.e., community hospital systems, and other cancer care providers). To bring new translational research to the community, Morehouse School of Medicine has initiated the Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of African American cancer patients, survivors, or those at risk of having cancer. This is not a treatment trial, but a longitudinal study designed to create a centralized cancer biorepository for precision medicine.","Through this protocol, Morehouse School of Medicine and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, investigators require an informed consent of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and\u002For other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.",[19,20],"Cancer","Cancer Risk",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},5000,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"PROCEDURE","Collection of blood, tissue, and other biological samples.","Behavioral health assessments, including quality of life.",[34],"Biospeciman Repository and Data Collection",[36],"Surveys",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Medical Chart Review","Health data abstracted directly from patient's health records",[34],[42,46,48],{"measure":43,"description":44,"timeFrame":45},"Improve Standard of Cancer Care","Establish a longitudinal clinical and related data and tissue repository that will contain cancer predisposing risk factors via surveys and questionnaires.","Time Frame: up to 20 years",{"measure":43,"description":47,"timeFrame":45},"Establish a longitudinal clinical and related data repository that will contain quality of life care via surveys and questionnaires",{"measure":43,"description":49,"timeFrame":45},"Establish a longitudinal tissue repository that will contain blood, tissue, and other biological samples other biological samples and associated clinical data collected from consenting patients.",[],"ALL","18 Years",{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria:\n\n1. 18 years of age and older.\n2. Diagnosed with cancer, or at risk for cancer. This includes anyone in the general population, but our primary focus will be on patients with a cancer diagnosis.\n3. Able to understand and sign the TCCP Informed Consent and Research Authorization form directly or through an authorized representative. The Informed Consent and Research Authorization will be available in both English and Spanish languages\n\nExclusion Criteria:\n\nNone\n\n\\-",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":13,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"Atlanta","Georgia","30310","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Margaret Hooker","CONTACT","404-752-1034","mhooker@msm.edu",{"lat":73,"lon":74},33.749,-84.38798,[76],{"name":77,"role":69,"phone":70,"email":78},"LaTrisha Horne","totalcancercare@msm.edu",[80],{"name":81,"affiliation":13,"role":82},"James W Lillard, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":88},[20,87],"Malignant Neoplasm",[],{"nct_id":4,"found":15,"summary":90,"prompt_version":99},{"design":91,"status":92,"heading":6,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an observational study planning to enroll 5000 participants. It involves collecting samples and reviewing medical charts.","completed","The Morehouse Total Cancer Care Protocol is an observational study aiming to improve cancer care, especially for African Americans. It involves collecting biological samples like blood and tissue, along with health information from your medical records and surveys. Researchers hope to use this information to find new ways to detect and treat cancer, and to develop personalized medicine. You can join if you are 18 or older and have been diagnosed with cancer or are at risk for cancer. The study aims to improve the standard of cancer care, with data being collected for up to 20 years. The current recruitment status is unclear.","Your health data will be collected from the time you join the study and will continue for your lifetime.",104,"You would provide blood, tissue, and other biological samples, answer behavioral health surveys, and allow researchers to review your medical records. Data collection will continue for your lifetime.","Not stated in the trial record.",[],"v2"]