Nctid:
NCT06611553
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D030361", "term"=>"Papillomavirus Infections"}, {"id"=>"D002583", "term"=>"Uterine Cervical Neoplasms"}], "ancestors"=>[{"id"=>"D014594", "term"=>"Uterine Neoplasms"}, {"id"=>"D005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D002577", "term"=>"Uterine Cervical Diseases"}, {"id"=>"D014591", "term"=>"Uterine Diseases"}, {"id"=>"D005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D014412", "term"=>"Tumor Virus Infections"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5830", "name"=>"Uterine Cervical Neoplasms", "asFound"=>"Cervical Cancer", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M23687", "name"=>"Papillomavirus Infections", "asFound"=>"Papillomavirus Infection", "relevance"=>"HIGH"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5825", "name"=>"Uterine Cervical Diseases", "relevance"=>"LOW"}, {"id"=>"M17339", "name"=>"Uterine Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M17162", "name"=>"Tumor Virus Infections", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"The study will have no blinding for participants and study staff. However, a unique study sample label schema will be utilized for both sample types when tested that will not permit linkages or identification of sample pairs thereby permitting unbiased testing and reporting."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>500}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-13", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2025-05-14", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-30", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02-14", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Human factors affecting usability", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be assessed by questionnaire data."}, {"measure"=>"Human factors affecting acceptability", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be assessed by questionnaire data."}, {"measure"=>"Human factors affecting preferences for self-collection", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be assessed by questionnaire data."}], "primaryOutcomes"=>[{"measure"=>"Clinical sensitivity for self-collected (SC) samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs)."}, {"measure"=>"Clinical sensitivity for clinician-collected (CC) samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV positive on CC sample given CIN2+. Will report point estimate and 95% CIs."}, {"measure"=>"Clinical specificity for SC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV negative on SC sample given \\< CIN2. Will report point estimate and 95% CIs."}, {"measure"=>"Clinical specificity for CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV negative on CC sample given \\< CIN2. Will report point estimate and 95% CIs."}, {"measure"=>"False positive rate (FPR) for SC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV positive on SC sample given \\< CIN2. Will report point estimate and 95% CIs."}, {"measure"=>"FPR for CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV positive on CC sample given \\< CIN2. Will report point estimate and 95% CIs."}, {"measure"=>"False negative rate (FNR) for SC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs."}, {"measure"=>"FNR for CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs."}, {"measure"=>"Sensitivity ratio for SC versus CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs."}, {"measure"=>"Specificity ratio for SC versus CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs."}, {"measure"=>"False positive (FP) ratio for SC versus CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"The FP ratio is the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs."}, {"measure"=>"False negative (FN) ratio for SC versus CC samples", "timeFrame"=>"One-time, up to 90 days", "description"=>"The FN ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs."}, {"measure"=>"Positive percent agreement", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs."}, {"measure"=>"Negative percent agreement", "timeFrame"=>"One-time, up to 90 days", "description"=>"Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs."}]}, "oversightModule"=>{"isUsExport"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cervical Carcinoma", "Human Papillomavirus Infection"]}, "descriptionModule"=>{"briefSummary"=>"This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.\n\nThe Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.", "detailedDescription"=>"PRIMARY OBJECTIVE:\n\nI. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by the Roche cobas HPV tests: Any high risk (HR) HPV genotype, HPV16, HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (combined).\n\nEXPLORATORY OBJECTIVE:\n\nI. To evaluate human factors affecting usability, acceptability, and preferences for self-collection.\n\nOUTLINE:\n\nPatients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.\n\nAfter completion of study intervention (one time), laboratory results available within 90 days are collected for study analysis purposes."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"25 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Willingness and ability to provide a documented informed consent\n* Is 25 years or older\n* Has an intact cervix\n* Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cell of undetermined significance \\[ASC-US\\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit\n* Willing and able to undergo colposcopy, and if clinically indicated for standard of care (SOC) purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable\n\nExclusion Criteria:\n\n* Is pregnant when presenting for the referral visit or gave birth within the past 3 months\n* Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \\[LEEP\\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit\n* Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records\n* Known medical conditions that, in the opinion of the investigator, preclude study participation\n* Previous participation in the SHIP Trial. Participation is defined as completing the self-collection\n* Is experiencing unusual bleeding or pelvic pain"}, "identificationModule"=>{"nctId"=>"NCT06611553", "briefTitle"=>"Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial", "orgStudyIdInfo"=>{"id"=>"NCI-2024-07726"}, "secondaryIdInfos"=>[{"id"=>"NCI-2024-07726", "type"=>"REGISTRY", "domain"=>"CTRP (Clinical Trial Reporting Program)"}, {"id"=>"LMI-001-A-S02", "type"=>"OTHER", "domain"=>"National Cancer Institute Division of Cancer Prevention"}, {"id"=>"LMI-001-A-S02", "type"=>"OTHER", "domain"=>"DCP"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Prevention (self-collected and clinician-collected samples)", "description"=>"Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.", "interventionNames"=>["Procedure: Biospecimen Collection", "Procedure: Cervical Biopsy", "Procedure: Colposcopy", "Other: Electronic Health Record Review", "Procedure: Endocervical Curettage", "Procedure: Excision", "Procedure: HPV Self-Collection", "Procedure: Human Papillomavirus Test", "Other: Questionnaire Administration", "Other: Survey Administration"]}], "interventions"=>[{"name"=>"Biospecimen Collection", "type"=>"PROCEDURE", "otherNames"=>["Biological Sample Collection", "Biospecimen Collected", "Specimen Collection"], "description"=>"Undergo collection of cervical sample by clinician", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Cervical Biopsy", "type"=>"PROCEDURE", "description"=>"Undergo cervical biopsy conducted by clinician", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Colposcopy", "type"=>"PROCEDURE", "otherNames"=>["CP"], "description"=>"Undergo colposcopy conducted by clinician", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Electronic Health Record Review", "type"=>"OTHER", "description"=>"Ancillary studies", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Endocervical Curettage", "type"=>"PROCEDURE", "description"=>"Undergo endocervical curettage conducted by clinician", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Excision", "type"=>"PROCEDURE", "otherNames"=>["Abscission", "Extirpation", "Surgical Removal"], "description"=>"Undergo cervical excisional procedure conducted by clinician", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"HPV Self-Collection", "type"=>"PROCEDURE", "otherNames"=>["At-home HPV Self Collection", "HPV Self Collection", "Human Papillomavirus Self-Collection"], "description"=>"Undertake self-collection of vaginal sample", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Human Papillomavirus Test", "type"=>"PROCEDURE", "otherNames"=>["HPV Assay", "HPV Test", "Human Papillomavirus"], "description"=>"Undergo HPV testing of self-collected vaginal sample and cervical sample", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Questionnaire Administration", "type"=>"OTHER", "description"=>"Ancillary studies", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}, {"name"=>"Survey Administration", "type"=>"OTHER", "description"=>"Ancillary studies", "armGroupLabels"=>["Prevention (self-collected and clinician-collected samples)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Warner K. Huh", "role"=>"CONTACT", "email"=>"whuh@uabmc.edu", "phone"=>"205-934-1555"}, {"name"=>"Warner K. Huh", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Alabama at Birmingham Cancer Center", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"94143", "city"=>"San Francisco", "state"=>"California", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"George Sawaya", "role"=>"CONTACT", "email"=>"george.sawaya@ucsf.edu", "phone"=>"415-351-8558"}, {"name"=>"George Sawaya", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"UCSF Medical Center-Parnassus", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"06520", "city"=>"New Haven", "state"=>"Connecticut", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Sangini Sheth", "role"=>"CONTACT", "email"=>"sangini.sheth@yale.edu", "phone"=>"203-887-9383"}, {"name"=>"Sangini Sheth", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Yale University", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Erin Kobetz-Kerman", "role"=>"CONTACT", "email"=>"ekobetz@med.miami.edu", "phone"=>"305-243-6185"}, {"name"=>"Erin Kobetz-Kerman", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Miami Miller School of Medicine-Sylvester Cancer Center", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"30322", "city"=>"Atlanta", "state"=>"Georgia", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Lisa C. Flowers", "role"=>"CONTACT", "email"=>"lflowe2@emory.edu", "phone"=>"678-596-3554"}, {"name"=>"Lisa C. Flowers", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Emory University Hospital/Winship Cancer Institute", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"40245", "city"=>"Louisville", "state"=>"Kentucky", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Tanya E. Franklin", "role"=>"CONTACT", "email"=>"tanya.franklin@louisville.edu", "phone"=>"502-561-7463"}, {"name"=>"Tanya E. Franklin", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"UofL Health Medical Center Northeast", "geoPoint"=>{"lat"=>38.25424, "lon"=>-85.75941}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michael E. Hagensee", "role"=>"CONTACT", "email"=>"mhagen@lsuhsc.edu", "phone"=>"504-210-3325"}, {"name"=>"Michael E. Hagensee", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Louisiana State University Health Science Center", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Jenell S. Coleman", "role"=>"CONTACT", "email"=>"colemanj@jhmi.edu", "phone"=>"410-614-4496"}, {"name"=>"Jenell S. Coleman", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Johns Hopkins University/Sidney Kimmel Cancer Center", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"48109", "city"=>"Ann Arbor", "state"=>"Michigan", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Diane M. Harper", "role"=>"CONTACT", "email"=>"harperdi@med.umich.edu", "phone"=>"734-998-7124"}, {"name"=>"Diane M. Harper", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Michigan Comprehensive Cancer Center", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"zip"=>"55417", "city"=>"Minneapolis", "state"=>"Minnesota", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Elisheva Danan", "role"=>"CONTACT", "email"=>"elizabeth.danan@va.gov", "phone"=>"612-629-7517"}, {"name"=>"Elisheva Danan", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Minneapolis VA Medical Center", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"39216", "city"=>"Jackson", "state"=>"Mississippi", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Carolann Risley", "role"=>"CONTACT", "email"=>"crisley@umc.edu", "phone"=>"228-217-2017"}, {"name"=>"Carolann Risley", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of Mississippi Medical Center", "geoPoint"=>{"lat"=>32.29876, "lon"=>-90.18481}}, {"zip"=>"87106", "city"=>"Albuquerque", "state"=>"New Mexico", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Cosette M. Wheeler", "role"=>"CONTACT", "email"=>"cwheeler@salud.unm.edu", "phone"=>"505-269-5817"}, {"name"=>"Cosette M. Wheeler", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University of New Mexico Cancer Center", "geoPoint"=>{"lat"=>35.08449, "lon"=>-106.65114}}, {"zip"=>"10461", "city"=>"Bronx", "state"=>"New York", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Mark H. Einstein", "role"=>"CONTACT", "email"=>"mark.einstein@einsteinmed.edu"}, {"name"=>"Mark H. Einstein", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Montefiore Medical Center-Einstein Campus", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"10065", "city"=>"New York", "state"=>"New York", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Denise A. Howard", "role"=>"CONTACT", "email"=>"deh3002@med.cornell.edu", "phone"=>"718-780-5204"}, {"name"=>"Denise A. Howard", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"NYP/Weill Cornell Medical Center", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"27599", "city"=>"Chapel Hill", "state"=>"North Carolina", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Lisa Rahangdale", "role"=>"CONTACT", "email"=>"lisa_rahangdale@med.unc.edu", "phone"=>"919-962-8331"}, {"name"=>"Lisa Rahangdale", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"UNC Lineberger Comprehensive Cancer Center", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"45219", "city"=>"Cincinnati", "state"=>"Ohio", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Leeya F. Pinder", "role"=>"CONTACT", "email"=>"pinderl@ucmail.uc.edu", "phone"=>"513-558-1332"}, {"name"=>"Leeya F. 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