- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06880055
Skjold etter godkjenningsstudieprotokoll (SOLAR)
The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Colorectal cancer (CRC) is the fourth most diagnosed cancer and second leading cause of cancer-related death in the US, with an estimated 53,010 deaths attributable to CRC in 2024. The risk of CRC increases with age, with the majority of cases and deaths occurring in individuals aged 65 years or older. While the incidence of CRC in Americans 65 years of age or older has decreased over the last decade, the incidence of CRC in younger Americans aged 55 years or younger has been increasing since the mid-1990s. CRC disproportionately affects minority populations, with American Indian/Alaska Native and Black/African American populations having the highest incidence and mortality rates1; this is further exacerbated by systemic barriers to current CRC screening options.
CRC primarily arises from a precursor lesion, the adenomatous polyp (i.e., adenoma), that grows from the epithelial cells of the colorectal mucosa. Adenomas that grow larger than 10 mm or have elements indicating a risk of malignant transformation (e.g., high-grade dysplasia or villous features) are defined as advanced adenomas (AAs). The vast number of adenomas, even those with features classifying them as AAs, do not progress into a colorectal malignancy. Colonoscopy cannot always distinguish adenomas or advanced adenomas from other polyp histology; thus, polypectomy is routinely performed for lesions identified on endoscopy. The transition rate from adenoma onset to CRC development is estimated to be 12.5 to 25 years. This slow transition from adenoma onset to CRC onset allows for multiple CRC screening opportunities over a lifetime, providing the ability to intervene along the disease development course and the potential to detect and remove adenomas, prevent colorectal cancer, and reduce CRC incidence and subsequently, disease mortality.
Once CRC has developed, tumor staging is consistent with other solid tumors and defined based on how far the cancer has spread within the body. In Stage 0 (carcinoma in situ), the cancer cells are only in the colorectal mucosa. In Stage I, the cancer has spread to the muscular layer of the colorectum but not to nearby tissue or lymph nodes. In Stage II, the cancer has grown through the wall of the colorectum and potentially to nearby tissues but has not spread to nearby lymph nodes. In Stage III, the cancer has spread to nearby lymph nodes but not to distant parts of the body. In Stage IV, the cancer has spread to one or more distant parts of the body. The estimated time frame from CRC onset to a symptomatic diagnosis of CRC is estimated to be 4-5 years, in the absence of early detection through asymptomatic cancer screening. Tumor size and location can influence the rate of transition through the stages of CRC. The 5-year survival rate for localized disease (Stage I-II) is 91%, and is 72% for regional disease (Stage III), while the 5-year survival for metastatic disease (Stage IV) is only 14%. These statistics highlight the ability to reduce CRC-related mortality by detection of early-stage (Stage I-III) disease where therapeutic intervention has the potential to result in a cure.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Hannah Oakley
- Telefonnummer: 415-307-2774
- E-post: solar@guardanthealth.com
Studiesteder
-
-
Arizona
-
Chandler, Arizona, Forente stater, 85224
- Rekruttering
- Southeast Valley Gastroenterology Consultants
-
Ta kontakt med:
- Charles Schron
- Telefonnummer: 480-899-2994
- E-post: cmsphoenix@aol.com
-
Hovedetterforsker:
- Charles Schron
-
Gilbert, Arizona, Forente stater, 85297
- Rekruttering
- Southeast Valley Gastroenterology Consultants
-
Ta kontakt med:
- Charles Schron
- Telefonnummer: 480-899-2994
- E-post: cmsphoenix@aol.com
-
Hovedetterforsker:
- Charles Schron
-
-
California
-
Anaheim, California, Forente stater, 92805
- Rekruttering
- Elite Primary Physicians, Inc.
-
Ta kontakt med:
- Brandon Bonilla
- Telefonnummer: 818-924-4708
- E-post: b.bonilla@amicisresearch.com
-
Hovedetterforsker:
- Ishminder Singh, MD
-
Canoga Park, California, Forente stater, 91304
- Rekruttering
- Alliance Research Institute, LLC
-
Ta kontakt med:
- Victor Odogwu
- Telefonnummer: 818-835-9085
- E-post: vodogwu@allianceri.org
-
Hovedetterforsker:
- Cameron Sikavi
-
Garden Grove, California, Forente stater, 92840
- Tilbaketrukket
- Paragon Rx Clinical, Inc.
-
Granada Hills, California, Forente stater, 91344
- Rekruttering
- Amicis Research Center
-
Ta kontakt med:
- Tyrone Rosales
- Telefonnummer: 818-924-4708
- E-post: tyrone.rosales@amicisresearch.com
-
Hovedetterforsker:
- Pascal Dabel
-
Monterey Park, California, Forente stater, 91754
- Rekruttering
- Ace Research Institute
-
Ta kontakt med:
- Jeovani Orellana
- Telefonnummer: 626-927-9915
- E-post: J.Orellana@AceResearchInstitute.com
-
Hovedetterforsker:
- Yu-Hsiang Sam Lee, MD
-
Palm Springs, California, Forente stater, 92262
- Rekruttering
- Desert Oasis Healthcare Medical Group
-
Hovedetterforsker:
- Michael F Jardula
-
Ta kontakt med:
- Brooke Yates
- Telefonnummer: 760-320-9505
- E-post: byates@mydohc.com
-
Sherman Oaks, California, Forente stater, 91403
- Rekruttering
- Amicis Research Center
-
Ta kontakt med:
- William Calder
- Telefonnummer: 818-464-4870
- E-post: w.calder@amicisresearch.com
-
Hovedetterforsker:
- Ali Sheybani, MD
-
Tarzana, California, Forente stater, 91356
- Rekruttering
- BioPartners, Inc
-
Ta kontakt med:
- Mila Gor
- Telefonnummer: 818-712-9355
-
Hovedetterforsker:
- Arkady Stern, MD
-
Valencia, California, Forente stater, 91355
- Rekruttering
- Amicis Research Center
-
Ta kontakt med:
- Veronica Macias
- Telefonnummer: 818-639-8822
- E-post: veronica.macias@amicisresearch.com
-
Hovedetterforsker:
- Dennis Lewis, MD
-
Winnetka, California, Forente stater, 91306
- Rekruttering
- Coral Clinics
-
Ta kontakt med:
- William Calder
- Telefonnummer: 818-924-4708
- E-post: w.calder@amicisresearch.com
-
Hovedetterforsker:
- Amin Khorsandi, MD
-
Woodland Hills, California, Forente stater, 91367
- Rekruttering
- BioPartners, Inc
-
Hovedetterforsker:
- Arkady Stern, MD
-
Ta kontakt med:
- Mila Gor
- Telefonnummer: 818-712-9355
- E-post: milla@biopartners-us.com
-
-
Connecticut
-
Branford, Connecticut, Forente stater, 06405
- Rekruttering
- Digestive Disease Associates
-
Ta kontakt med:
- Lillian Urrutia
- Telefonnummer: 561-453-3215
- E-post: Lurrutia@yanuvia.com
-
Hovedetterforsker:
- Daniel Zanchetti
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Daniel Zanchetti, MD
-
-
Florida
-
Boca Raton, Florida, Forente stater, 33486
- Rekruttering
- Gastroenterology Consultants of Boca Raton, LLC
-
Ta kontakt med:
- Lillian Urrutia
- Telefonnummer: 561-453-3215
- E-post: Lurrutia@yanuvia.com
-
Hovedetterforsker:
- Todd Eisner
-
Delray Beach, Florida, Forente stater, 33484
- Rekruttering
- Manuel Espinel MD PA
-
Ta kontakt med:
- Kristell Vazquez
- Telefonnummer: 561-501-4646
- E-post: kristell.vazquez92@gmail.com
-
Hovedetterforsker:
- Manuel Espinel, MD
-
Doral, Florida, Forente stater, 33172
- Rekruttering
- Innova Pharma Research, LLC
-
Hovedetterforsker:
- Giralt Yanez, MD
-
Ta kontakt med:
- Mario Llobet
- Telefonnummer: 305-200-5646
- E-post: mllobet@innovapresearch.com
-
Miami, Florida, Forente stater, 33134
- Rekruttering
- Research Associates of South Florida, LLC
-
Ta kontakt med:
- Stephany Moreno
- Telefonnummer: 786-476-8790
- E-post: smoreno@researchassociatesfl.com
-
Hovedetterforsker:
- Christian Andrade, MD
-
Miami, Florida, Forente stater, 33134
- Rekruttering
- Marisela Gonzalez, MD
-
Ta kontakt med:
- Milagros Fernandez
- Telefonnummer: 305-220-3700
- E-post: mfernandez@mariselagonzalezmdpa.net
-
Hovedetterforsker:
- Marisela Gonzalez, MD
-
Miami, Florida, Forente stater, 33166
- Rekruttering
- Florida South Research Phase I-IV, Inc.
-
Ta kontakt med:
- Lisbelle Revoredo
- Telefonnummer: 305-418-0847
- E-post: Lrevoredo@southfloridatrials.com
-
Hovedetterforsker:
- Eduardo Viera, MD
-
North Miami, Florida, Forente stater, 33181
- Rekruttering
- Physicians Group of South Florida
-
Ta kontakt med:
- Daniel Wolfson
- Telefonnummer: 305-609-1349
- E-post: danielwolfson1126@yahoo.com
-
Hovedetterforsker:
- Daniel Wolfson
-
Tamarac, Florida, Forente stater, 33321
- Rekruttering
- Infinity Life Research Group, LLC
-
Ta kontakt med:
- Millie Herrera
- Telefonnummer: 754-253-8555
- E-post: millie@infinityliferesearch.com
-
Hovedetterforsker:
- Lazaro Diaz, MD
-
Tampa, Florida, Forente stater, 33607
- Rekruttering
- NMC Research
-
Ta kontakt med:
- Jose Martinez
- Telefonnummer: 813-374-0568
- E-post: jmartinez@nmc-research.com
-
Hovedetterforsker:
- Osvanny Nodal, MD
-
Tampa, Florida, Forente stater, 33634
- Rekruttering
- Top Research of West Florida, LLC
-
Hovedetterforsker:
- Jorge Castillo Molina, MD
-
Ta kontakt med:
- Mabel Diaz
- Telefonnummer: 813-290-0648
- E-post: mdiaz@topresearch.org
-
-
Georgia
-
Conyers, Georgia, Forente stater, 30094
- Rekruttering
- Keith Family Medicine
-
Ta kontakt med:
- Morgan Patterson
- Telefonnummer: 770-929-1115
- E-post: keithfamilymanager@gmail.com
-
Hovedetterforsker:
- Nabil Keith, MD
-
Dawsonville, Georgia, Forente stater, 30534
- Rekruttering
- Keith Family Medicine
-
Hovedetterforsker:
- Nabil Keith, MD
-
Ta kontakt med:
- Taylor Cash
- Telefonnummer: 706-216-4444
- E-post: taylordcash@yahoo.com
-
Fayetteville, Georgia, Forente stater, 30214
- Rekruttering
- Primeway Clinical Research Group
-
Ta kontakt med:
- Celine Kalu
- Telefonnummer: 678-368-7197
- E-post: celinek@primewayclinicalresearch.com
-
Hovedetterforsker:
- Charlita Worthy, MD
-
Snellville, Georgia, Forente stater, 30078
- Rekruttering
- CLINsearch at Renew Health Clinical Research
-
Ta kontakt med:
- Javonte Maynor
- Telefonnummer: 706-223-3560
- E-post: javonte.maynor@renewhealthcr.com
-
Hovedetterforsker:
- Ayyaz Qureshi, MD
-
-
Illinois
-
Bourbonnais, Illinois, Forente stater, 60914
- Rekruttering
- Digestive Disease Consultants
-
Hovedetterforsker:
- Ashish Shah, MD
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Hovedetterforsker:
- Ashish Shah
-
Champaign, Illinois, Forente stater, 61822
- Rekruttering
- Christie Clinic
-
Ta kontakt med:
- Andrew Bartlett
- Telefonnummer: 217-366-1331
- E-post: abartlett@christieclinic.com
-
Champaign, Illinois, Forente stater, 61822
- Aktiv, ikke rekrutterende
- Christie Clinic
-
Chicago, Illinois, Forente stater, 60631
- Rekruttering
- GI Solutions of Illinois
-
Hovedetterforsker:
- Charles Berkelhammer, MD
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Hovedetterforsker:
- Charles Berkelhammer
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Downers Grove, Illinois, Forente stater, 60515
- Rekruttering
- Digestive Health Services
-
Hovedetterforsker:
- Charles Berkelhammer, MD
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Hovedetterforsker:
- Charles Berkelhammer
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Lake Barrington, Illinois, Forente stater, 60010
- Rekruttering
- Gastroenterology and Internal Medicine Specialists (GAIMS)
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Hovedetterforsker:
- Nicole Gentile
-
Hovedetterforsker:
- Nicole Gentile, MD
-
Libertyville, Illinois, Forente stater, 60048
- Rekruttering
- Northshore Center for Gastroenterology (NCG)
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Hovedetterforsker:
- Nicole Gentile, MD
-
Oak Lawn, Illinois, Forente stater, 60453
- Rekruttering
- Southwest Gastroenterology (SWG)
-
Hovedetterforsker:
- Charles Berkelhammer, MD
-
Ta kontakt med:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-post: hboxwalla@avicennaclinical.com
-
Hovedetterforsker:
- Charles Berkelhammer
-
Ta kontakt med:
- Hussain Boxwalla Chief Operating Officer/Owner
- Telefonnummer: (708) 860-7866
- E-post: hboxwalla@avicennaclinical.com
-
-
Indiana
-
Munster, Indiana, Forente stater, 46321
- Rekruttering
- Center for Digestive Health
-
Ta kontakt med:
- Amir Husain
- Telefonnummer: 630-605-1522
- E-post: amir.husain@avicennaclinical.com
-
Hovedetterforsker:
- Navin Kumar, MD
-
-
Kansas
-
Hutchinson, Kansas, Forente stater, 67502
- Aktiv, ikke rekrutterende
- Hutchinson Clinic
-
-
Louisiana
-
Covington, Louisiana, Forente stater, 70433
- Rekruttering
- Northlake Gastroenterology Associates
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Gregory Mula
-
Hammond, Louisiana, Forente stater, 70403
- Rekruttering
- Northlake Gastroenterology Associates
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Gregory Mula
-
-
Maryland
-
Olney, Maryland, Forente stater, 20832
- Rekruttering
- Olney Medical Group
-
Ta kontakt med:
- Jnanu Shahi
- Telefonnummer: 301-774-5260
- E-post: jnanushrestha@yahoo.com
-
Hovedetterforsker:
- Gaurang Thaker, MD
-
-
Michigan
-
Bloomfield Township, Michigan, Forente stater, 48302
- Rekruttering
- Embassy Research Network
-
Ta kontakt med:
- Zander Minano
- Telefonnummer: 248-622-4083
- E-post: zminano@embassyresearch.com
-
Hovedetterforsker:
- Priyesh Patel, MD
-
Clarkston, Michigan, Forente stater, 48346
- Rekruttering
- Tanir Medical Center, PC
-
Ta kontakt med:
- Reha Avci
- Telefonnummer: 248-620-3700
- E-post: rehaavci@tanirmedicalcenter.com
-
Hovedetterforsker:
- Narin Tanir-Avci, MD
-
-
Mississippi
-
Ridgeland, Mississippi, Forente stater, 39157
- Rekruttering
- Quinn Healthcare, PLLC
-
Hovedetterforsker:
- Timothy Quinn, MD
-
Ta kontakt med:
- Khadijra Lockwood
- Telefonnummer: 601-487-6482
- E-post: Khadijra.lockwood@roviaclinical.com
-
-
New Jersey
-
Clifton, New Jersey, Forente stater, 07013
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Steven Gronowitz
-
Hackensack, New Jersey, Forente stater, 07601
- Aktiv, ikke rekrutterende
- Gastroenterology Associates of New Jersey
-
Montclair, New Jersey, Forente stater, 07042
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Steven Gronowitz
-
Ridgewood, New Jersey, Forente stater, 07450
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Steven Gronowitz
-
Wayne, New Jersey, Forente stater, 07470
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Steven Gronowitz
-
Wayne, New Jersey, Forente stater, 07470
- Aktiv, ikke rekrutterende
- Gastroenterology Associates of New Jersey
-
-
New York
-
Camillus, New York, Forente stater, 13031
- Rekruttering
- Associated Gastroenterologists of Central New York
-
Hovedetterforsker:
- John Sun
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
East Syracuse, New York, Forente stater, 13057
- Rekruttering
- Syracuse Gastroenterological Associates, P.C.
-
Hovedetterforsker:
- Dennis Reedy
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Fayetteville, New York, Forente stater, 13066
- Rekruttering
- Associated Gastroenterologists of Central New York
-
Hovedetterforsker:
- John Sun
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
New York, New York, Forente stater, 10010
- Rekruttering
- NYU Langone
-
Ta kontakt med:
- Anika Zaman
- Telefonnummer: (212) 686-7500 ext 15745
- E-post: anika.zaman@nyulangone.org
-
Hovedetterforsker:
- Peter Liang, MD
-
Orchard Park, New York, Forente stater, 14127
- Rekruttering
- Orchard Park Family Practice
-
Ta kontakt med:
- Elizabeth Swanson
- Telefonnummer: 716-339-3666
- E-post: swanson@circuitclinical.com
-
Hovedetterforsker:
- Richard Ruh
-
Valley Stream, New York, Forente stater, 11581
- Rekruttering
- GastroCare LI
-
Hovedetterforsker:
- Brandon Rieders
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Hovedetterforsker:
- Brandon Rieders, MD
-
-
North Carolina
-
Cary, North Carolina, Forente stater, 27518
- Rekruttering
- Cary Gastroenterology Associates
-
Hovedetterforsker:
- Michael Brody
-
Ta kontakt med:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-post: abernegger@yanuvia.com
-
Chapel Hill, North Carolina, Forente stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill
-
Hovedetterforsker:
- Sarah McGill, MD
-
Ta kontakt med:
- Shilpa Karanjit
- Telefonnummer: 919-843-8519
- E-post: shilpa_karanjit@med.unc.edu
-
Chapel Hill, North Carolina, Forente stater, 27514
- Rekruttering
- University of North Carolina at Chapel Hill
-
Hovedetterforsker:
- Sarah McGill, MD
-
Ta kontakt med:
- Shilpa Karanjit
- Telefonnummer: 919-843-8519
- E-post: shilpa_karanjit@med.unc.edu
-
Hillsborough, North Carolina, Forente stater, 27278
- Rekruttering
- University of North Carolina at Chapel Hill
-
Hovedetterforsker:
- Sarah McGill, MD
-
Ta kontakt med:
- Shilpa Karanjit
- Telefonnummer: 919-843-8519
- E-post: shilpa_karanjit@med.unc.edu
-
Mocksville, North Carolina, Forente stater, 27028
- Aktiv, ikke rekrutterende
- Piedmont Healthcare, P.A.
-
Pinehurst, North Carolina, Forente stater, 28374
- Tilbaketrukket
- Pinehurst Medical Clinic
-
Sanford, North Carolina, Forente stater, 27330
- Tilbaketrukket
- Sanford Cardiology Pinehurst Medical Clinic
-
Statesville, North Carolina, Forente stater, 28625
- Aktiv, ikke rekrutterende
- Piedmont Healthcare LLC
-
-
Pennsylvania
-
Altoona, Pennsylvania, Forente stater, 16602
- Rekruttering
- US Digestive Health at Blair
-
Hovedetterforsker:
- Mitul Patel
-
Ta kontakt med:
- Amanda Bianconi
- Telefonnummer: 3102 814-946-5469
- E-post: abianconi@usdhealth.com
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania
-
Hovedetterforsker:
- Bryson Katona, MD
-
Ta kontakt med:
- Alexis Winters
- Telefonnummer: 215-349-8222
- E-post: alexis.winters@pennmedicine.upenn.edu
-
Pottstown, Pennsylvania, Forente stater, 19464
- Rekruttering
- Health Living at Pottstown Medical Specialists, Inc
-
Ta kontakt med:
- Stacy Cowden
- Telefonnummer: 610-858-9174
- E-post: scowden@circuitclinical.com
-
Hovedetterforsker:
- Wade Brosius
-
-
Texas
-
Austin, Texas, Forente stater, 78735
- Aktiv, ikke rekrutterende
- Premier Family Physicians
-
Austin, Texas, Forente stater, 78746
- Aktiv, ikke rekrutterende
- Premier Family Physicians
-
Garland, Texas, Forente stater, 75043
- Rekruttering
- Broadway Medical Clinic
-
Ta kontakt med:
- Ana Goytia
- Telefonnummer: 972-240-8539
- E-post: anaisagoytia2@gmail.com
-
Hovedetterforsker:
- Mohammed Al-Haider, MD
-
Houston, Texas, Forente stater, 77090
- Rekruttering
- Integrity Advanced Therapeutics, PLLC
-
Ta kontakt med:
- Scott Ward
- Telefonnummer: 281-453-2005
- E-post: scott.ward@iat.care
-
Hovedetterforsker:
- Howard Hamat
-
Paris, Texas, Forente stater, 75460
- Rekruttering
- Paris Family Physicians
-
Ta kontakt med:
- Katie Stringer
- Telefonnummer: 903-785-4362
- E-post: katiestringer00@yahoo.com
-
Hovedetterforsker:
- Alois Pauls, MD
-
Shenandoah, Texas, Forente stater, 77384
- Rekruttering
- Center for Digestive Disease
-
Hovedetterforsker:
- Shail Maheshwari
-
Ta kontakt med:
- Melissa Clark
- Telefonnummer: 936-321-5440
- E-post: melissa.clark@cddgastro.net
-
Tomball, Texas, Forente stater, 77375
- Rekruttering
- Horizon Clinical Research Group
-
Hovedetterforsker:
- Amar Dodda
-
Ta kontakt med:
- Shatabdi Satpathi
- Telefonnummer: 281-803-9960
- E-post: shatabdi@horizoncrg.com
-
Hovedetterforsker:
- Amar Dodda, MD
-
-
Virginia
-
Williamsburg, Virginia, Forente stater, 23188
- Rekruttering
- Tidewater Physician Multispecialty Group Clinical Research
-
Hovedetterforsker:
- Frances Jones
-
Ta kontakt med:
- Gabrielle Land
- Telefonnummer: 757-707-3503
- E-post: gabrielle.land@tpmgpc.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study
Beskrivelse
Inclusion Criteria:
- Subjects aged 45-81 years at time of consent
- Intending to undergo a standard of care Shield test
- Considered by a physician or healthcare provider as being of 'average risk' for CRC; 'Average-risk' individuals in the context of CRC screening are defined as those who do not have symptoms of CRC and do not have increased risk factors for the disease (i.e., prior diagnosis of CRC, adenomatous polyps, or inflammatory bowel disease; family history of CRC or known hereditary predisposition to CRC).
- Subject agrees to comply with study procedures and associated standard of care assessments.
Exclusion Criteria:
-
Undergoing colonoscopy for investigation of symptoms
-
Personal history of colorectal cancer (CRC), adenomas, or other related cancers
-
Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age
-
Positive result on another colorectal cancer screening method within the last six months, or:
- 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT)
- 36 months for FIT-DNA test
-
Personal history of any of the following high-risk conditions for colorectal cancer:
-
Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease
-
Familial adenomatous polyposis (FAP)
-
Other hereditary cancer syndromes including but not limited to:
- Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz- Jeghers Syndrome, MUTYH Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
-
-
Positive Shield test result within the previous 3 years
-
History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
-
Known diagnosis of inflammatory bowel disease
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Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
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Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
-
Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study
-
Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Enrolled Subjects
Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study. |
Shield Blood Test for colo-rectal cancer Screening |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Performance measures of the Shield test will be assessed for the second testing interval
Tidsramme: 33-42 Months Post-Enrollment
|
|
33-42 Months Post-Enrollment
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07-GI-003
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .