Spots Global Cancer Trial Database for Screening for High Frequency Malignant Disease
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Trial Identification
Brief Title: Screening for High Frequency Malignant Disease
Official Title: Screening for High Frequency Malignant Disease
Study ID: NCT05117840
Conditions
Interventions
Study Description
Brief Summary: The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.
Detailed Description: The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations. The SHIELD study will recruit patients in separate cancer-risk cohorts with specified pathways for cancer screening. Patients eligible for high frequency cancer screening will be screened for study eligibility per each cohort's criteria (see appendixes). Within each cohort, individuals eligible for the study will be consented for the investigational blood draw and applicable questionnaires within 90 days of standard of care screening method and prior to any invasive procedure for cancer diagnosis and/or treatment (T0). Subjects will have at least 2 follow-up visits at 1 year and 2 years (T1 and T2) since the index blood draw during the study. Additional follow-up is defined per each cohort. Updated medical data, repeat investigational blood draw and study questionnaires will be collected at follow-up intervals per each cohort's study procedure. The first cohort to be recruited will be designated as cohort A for lung cancer screening (appendix 1). Additional baskets with other cancer-risk cohorts of interest will be considered and added as the study expands. Additional appendixes will be designed for these cohorts at that time.
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Highlands Oncology Group PA, Fayetteville, Arkansas, United States
Pacific Cancer Medical Center, Anaheim, California, United States
SoCal Clinical Research, Fountain Valley, California, United States
Paragon Rx Clinical, Garden Grove, California, United States
National Institute for Clinical Research, Garden Grove, California, United States
Advanced Investigative Medicine, Hawthorne, California, United States
California Medical Research Associates Inc., Northridge, California, United States
National Institute for Clinical Research, Pomona, California, United States
Starling Physicians, New Britain, Connecticut, United States
Central Florida Pulmonary Group, P.A., Altamonte Springs, Florida, United States
Pulmonary, Critical Care & Sleep Disorders Institute of South Florida, Atlantis, Florida, United States
Bay Area Chest Physicians, P.A., Clearwater, Florida, United States
CTMD Research, Coconut Creek, Florida, United States
Life Arc Research Centers, Coral Gables, Florida, United States
Pulmonary Physicians of South Florida, LLC, Coral Springs, Florida, United States
SIMED Health, LLC, Gainesville, Florida, United States
National Research Institute, Hialeah, Florida, United States
3Sync Research, Hialeah, Florida, United States
Cano Research, Hollywood, Florida, United States
WS-Multi-Specialty Research Associates, Lake City, Florida, United States
3Sync Research, Lake Worth, Florida, United States
Charisma Medical and Research Center, Miami Lakes, Florida, United States
Cano Research, Miami, Florida, United States
Las Mias Research and Medical Center, Miami, Florida, United States
Monzon Clinical Trials, Miami, Florida, United States
Alma Clinical Research, Miami, Florida, United States
Valencia Medical and Research Center, Miami, Florida, United States
Miami Pulmonary Specialists, Miami, Florida, United States
Florida Research Center, Inc., Miami, Florida, United States
De La Cruz Research Center, Miami, Florida, United States
Adult Medicine of Lake County, Mount Dora, Florida, United States
Central Florida Pulmonary Group, P.A., Orlando, Florida, United States
Cano Research, Orlando, Florida, United States
Central Florida Pulmonary Group, P.A., Orlando, Florida, United States
CTMD Research, Palm Springs, Florida, United States
Jorge Barros, MVPA, Pembroke Pines, Florida, United States
Pinellas Medical Research, LLC, Saint Petersburg, Florida, United States
Genesis Clinical, Tampa, Florida, United States
Adtremed Research Clinic, Tampa, Florida, United States
VICIS Clinical Research, Tampa, Florida, United States
Midtown OB/GYN North, Columbus, Georgia, United States
DC Research Works, Marietta, Georgia, United States
Christie Clinic, Champaign, Illinois, United States
Cano Research, Chicago, Illinois, United States
Hutchinson Clinic - North Waldron, Hutchinson, Kansas, United States
HealthPartners Institute, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Somnos Clinical Research, Lincoln, Nebraska, United States
Great Plains Health, North Platte, Nebraska, United States
Ocean Pulmonary Associates, Brick, New Jersey, United States
RespaCare, Bridgewater, New Jersey, United States
Pulmonary & Sleep Disorders of New Jersey, East Brunswick, New Jersey, United States
Pulmonary Internists, Edison, New Jersey, United States
Pulmonary Specialists of North Jersey, Englewood, New Jersey, United States
Respiratory and Sleep Specialists, LLC, Kendall Park, New Jersey, United States
MedCorps Asthma and Pulmonary Specialists, Linwood, New Jersey, United States
Pulmonary & Sleep Disorders of New Jersey, Monroe, New Jersey, United States
Pulmonary Specialists of North Jersey, North Bergen, New Jersey, United States
Respiratory and Sleep Specialists, LLC, Princeton, New Jersey, United States
North Jersey Pulmonary Associates, Ridgewood, New Jersey, United States
MedCorps Asthma and Pulmonary Specialists, Sewell, New Jersey, United States
Ocean Pulmonary Associates, Toms River, New Jersey, United States
Long Island Pulmonary and Sleep Medicine Associates, Hempstead, New York, United States
Kamelhar-Teller Pulmonology, New York, New York, United States
Long Island Pulmonary and Sleep Medicine Associates, Rockville Centre, New York, United States
Great Lakes Medical Research, Westfield, New York, United States
CTMD Research, Asheville, Asheville, North Carolina, United States
Durham VA Medical Center, Durham, North Carolina, United States
Clinical Research of Gastonia, Gastonia, North Carolina, United States
Peters Medical Research, High Point, North Carolina, United States
Piedmont Healthcare, Statesville, North Carolina, United States
Wilmington Health, Wilmington, North Carolina, United States
Lillestol Research, LLC, Fargo, North Dakota, United States
Gabrail Cancer Center, Canton, Ohio, United States
Pulmonology Associates Inc., Broomall, Pennsylvania, United States
Pulmonology Associates Inc., Paoli, Pennsylvania, United States
Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108), Wynnewood, Pennsylvania, United States
Pulmonology Associates Inc., Wynnewood, Pennsylvania, United States
Respiratory Specialists, Wyomissing, Pennsylvania, United States
Vista Clinical Research, Columbia, South Carolina, United States
The Jackson Clinic, Jackson, Tennessee, United States
ARC Clinical Research at William Cannon, Austin, Texas, United States
Pulmonary Critical Care & Sleep Associates, P.A., Conroe, Texas, United States
Houston Pulmonary Sleep, Allergy, and Asthma Associates, Cypress, Texas, United States
Southwest Family Medicine Associates, Dallas, Texas, United States
UT Southwestern, Dallas, Texas, United States
El Paso Pulmonary Associates, El Paso, Texas, United States
Mt. Olympus Medical Research, Friendswood, Texas, United States
Best Cancer Care & Hematology - Biopharma Informatic, Houston, Texas, United States
3Sync Research, Kingwood, Texas, United States
Joe Arrington Cancer Research, Lubbock, Texas, United States
Wellness Clinical Research, McKinney, Texas, United States
PRX Research, Mesquite, Texas, United States
Oak Cliff Research, Richardson, Texas, United States
Sugar Lakes Family Practice, PA, Sugar Land, Texas, United States
Tidewater Physicians Multispecialty Group, P.C., Williamsburg, Virginia, United States
Western Washington Medical Group, Inc, Everett, Washington, United States
The Vancouver Clinic, Vancouver, Washington, United States
Mayo Clinic Health System Eau Claire, Eau Claire, Wisconsin, United States
Mayo Clinic La Crosse, La Crosse, Wisconsin, United States
Centre Hospitalier d'Abbeville, Abbeville, , France
CHU Amiens Picardie - Centre de Recherche Clinique, Amiens, , France
Infirmerie Protestante de Lyon, Caluire-et-Cuire, , France
Hôpitaux du Léman, Thonon-les-Bains, , France
Hospital Vithas Xanit Internacional, Benalmádena, AN, Spain
Hospital Recoletas Campo Grande, Valladolid, CL, Spain
Consulta Respira, Mataró, CT, Spain
Hospital HM Montepríncipe, Boadilla del Monte, MD, Spain
Hospital MD Anderson Cancer Center Madrid, Madrid, MD, Spain
Hospital HM Sanchinarro, Madrid, MD, Spain
Hospital HM Puerta del Sur, Móstoles, MD, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón, MD, Spain
Contact Details
Name: Ha Nguyen, MD
Affiliation: Guardant Health, Inc.
Role: STUDY_DIRECTOR
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