- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06880055
Shield Post-godkendelsesprotokol (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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Hannah Oakley
- Telefonnummer: 415-307-2774
- E-mail: solar@guardanthealth.com
Studiesteder
-
-
Arizona
-
Chandler, Arizona, Forenede Stater, 85224
- Rekruttering
- Southeast Valley Gastroenterology Consultants
-
Kontakt:
- Charles Schron
- Telefonnummer: 480-899-2994
- E-mail: cmsphoenix@aol.com
-
Ledende efterforsker:
- Charles Schron
-
Gilbert, Arizona, Forenede Stater, 85297
- Rekruttering
- Southeast Valley Gastroenterology Consultants
-
Kontakt:
- Charles Schron
- Telefonnummer: 480-899-2994
- E-mail: cmsphoenix@aol.com
-
Ledende efterforsker:
- Charles Schron
-
-
California
-
Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Elite Primary Physicians, Inc.
-
Kontakt:
- Brandon Bonilla
- Telefonnummer: 818-924-4708
- E-mail: b.bonilla@amicisresearch.com
-
Ledende efterforsker:
- Ishminder Singh, MD
-
Canoga Park, California, Forenede Stater, 91304
- Rekruttering
- Alliance Research Institute, LLC
-
Kontakt:
- Victor Odogwu
- Telefonnummer: 818-835-9085
- E-mail: vodogwu@allianceri.org
-
Ledende efterforsker:
- Cameron Sikavi
-
Garden Grove, California, Forenede Stater, 92840
- Trukket tilbage
- Paragon Rx Clinical, Inc.
-
Granada Hills, California, Forenede Stater, 91344
- Rekruttering
- Amicis Research Center
-
Kontakt:
- Tyrone Rosales
- Telefonnummer: 818-924-4708
- E-mail: tyrone.rosales@amicisresearch.com
-
Ledende efterforsker:
- Pascal Dabel
-
Monterey Park, California, Forenede Stater, 91754
- Rekruttering
- Ace Research Institute
-
Kontakt:
- Jeovani Orellana
- Telefonnummer: 626-927-9915
- E-mail: J.Orellana@AceResearchInstitute.com
-
Ledende efterforsker:
- Yu-Hsiang Sam Lee, MD
-
Palm Springs, California, Forenede Stater, 92262
- Rekruttering
- Desert Oasis Healthcare Medical Group
-
Ledende efterforsker:
- Michael F Jardula
-
Kontakt:
- Brooke Yates
- Telefonnummer: 760-320-9505
- E-mail: byates@mydohc.com
-
Sherman Oaks, California, Forenede Stater, 91403
- Rekruttering
- Amicis Research Center
-
Kontakt:
- William Calder
- Telefonnummer: 818-464-4870
- E-mail: w.calder@amicisresearch.com
-
Ledende efterforsker:
- Ali Sheybani, MD
-
Tarzana, California, Forenede Stater, 91356
- Rekruttering
- BioPartners, Inc
-
Kontakt:
- Mila Gor
- Telefonnummer: 818-712-9355
-
Ledende efterforsker:
- Arkady Stern, MD
-
Valencia, California, Forenede Stater, 91355
- Rekruttering
- Amicis Research Center
-
Kontakt:
- Veronica Macias
- Telefonnummer: 818-639-8822
- E-mail: veronica.macias@amicisresearch.com
-
Ledende efterforsker:
- Dennis Lewis, MD
-
Winnetka, California, Forenede Stater, 91306
- Rekruttering
- Coral Clinics
-
Kontakt:
- William Calder
- Telefonnummer: 818-924-4708
- E-mail: w.calder@amicisresearch.com
-
Ledende efterforsker:
- Amin Khorsandi, MD
-
Woodland Hills, California, Forenede Stater, 91367
- Rekruttering
- BioPartners, Inc
-
Ledende efterforsker:
- Arkady Stern, MD
-
Kontakt:
- Mila Gor
- Telefonnummer: 818-712-9355
- E-mail: milla@biopartners-us.com
-
-
Connecticut
-
Branford, Connecticut, Forenede Stater, 06405
- Rekruttering
- Digestive Disease Associates
-
Kontakt:
- Lillian Urrutia
- Telefonnummer: 561-453-3215
- E-mail: Lurrutia@yanuvia.com
-
Ledende efterforsker:
- Daniel Zanchetti
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Daniel Zanchetti, MD
-
-
Florida
-
Boca Raton, Florida, Forenede Stater, 33486
- Rekruttering
- Gastroenterology Consultants of Boca Raton, LLC
-
Kontakt:
- Lillian Urrutia
- Telefonnummer: 561-453-3215
- E-mail: Lurrutia@yanuvia.com
-
Ledende efterforsker:
- Todd Eisner
-
Delray Beach, Florida, Forenede Stater, 33484
- Rekruttering
- Manuel Espinel MD PA
-
Kontakt:
- Kristell Vazquez
- Telefonnummer: 561-501-4646
- E-mail: kristell.vazquez92@gmail.com
-
Ledende efterforsker:
- Manuel Espinel, MD
-
Doral, Florida, Forenede Stater, 33172
- Rekruttering
- Innova Pharma Research, LLC
-
Ledende efterforsker:
- Giralt Yanez, MD
-
Kontakt:
- Mario Llobet
- Telefonnummer: 305-200-5646
- E-mail: mllobet@innovapresearch.com
-
Miami, Florida, Forenede Stater, 33134
- Rekruttering
- Research Associates of South Florida, LLC
-
Kontakt:
- Stephany Moreno
- Telefonnummer: 786-476-8790
- E-mail: smoreno@researchassociatesfl.com
-
Ledende efterforsker:
- Christian Andrade, MD
-
Miami, Florida, Forenede Stater, 33134
- Rekruttering
- Marisela Gonzalez, MD
-
Kontakt:
- Milagros Fernandez
- Telefonnummer: 305-220-3700
- E-mail: mfernandez@mariselagonzalezmdpa.net
-
Ledende efterforsker:
- Marisela Gonzalez, MD
-
Miami, Florida, Forenede Stater, 33166
- Rekruttering
- Florida South Research Phase I-IV, Inc.
-
Kontakt:
- Lisbelle Revoredo
- Telefonnummer: 305-418-0847
- E-mail: Lrevoredo@southfloridatrials.com
-
Ledende efterforsker:
- Eduardo Viera, MD
-
North Miami, Florida, Forenede Stater, 33181
- Rekruttering
- Physicians Group of South Florida
-
Kontakt:
- Daniel Wolfson
- Telefonnummer: 305-609-1349
- E-mail: danielwolfson1126@yahoo.com
-
Ledende efterforsker:
- Daniel Wolfson
-
Tamarac, Florida, Forenede Stater, 33321
- Rekruttering
- Infinity Life Research Group, LLC
-
Kontakt:
- Millie Herrera
- Telefonnummer: 754-253-8555
- E-mail: millie@infinityliferesearch.com
-
Ledende efterforsker:
- Lazaro Diaz, MD
-
Tampa, Florida, Forenede Stater, 33607
- Rekruttering
- NMC Research
-
Kontakt:
- Jose Martinez
- Telefonnummer: 813-374-0568
- E-mail: jmartinez@nmc-research.com
-
Ledende efterforsker:
- Osvanny Nodal, MD
-
Tampa, Florida, Forenede Stater, 33634
- Rekruttering
- Top Research of West Florida, LLC
-
Ledende efterforsker:
- Jorge Castillo Molina, MD
-
Kontakt:
- Mabel Diaz
- Telefonnummer: 813-290-0648
- E-mail: mdiaz@topresearch.org
-
-
Georgia
-
Conyers, Georgia, Forenede Stater, 30094
- Rekruttering
- Keith Family Medicine
-
Kontakt:
- Morgan Patterson
- Telefonnummer: 770-929-1115
- E-mail: keithfamilymanager@gmail.com
-
Ledende efterforsker:
- Nabil Keith, MD
-
Dawsonville, Georgia, Forenede Stater, 30534
- Rekruttering
- Keith Family Medicine
-
Ledende efterforsker:
- Nabil Keith, MD
-
Kontakt:
- Taylor Cash
- Telefonnummer: 706-216-4444
- E-mail: taylordcash@yahoo.com
-
Fayetteville, Georgia, Forenede Stater, 30214
- Rekruttering
- Primeway Clinical Research Group
-
Kontakt:
- Celine Kalu
- Telefonnummer: 678-368-7197
- E-mail: celinek@primewayclinicalresearch.com
-
Ledende efterforsker:
- Charlita Worthy, MD
-
Snellville, Georgia, Forenede Stater, 30078
- Rekruttering
- CLINsearch at Renew Health Clinical Research
-
Kontakt:
- Javonte Maynor
- Telefonnummer: 706-223-3560
- E-mail: javonte.maynor@renewhealthcr.com
-
Ledende efterforsker:
- Ayyaz Qureshi, MD
-
-
Illinois
-
Bourbonnais, Illinois, Forenede Stater, 60914
- Rekruttering
- Digestive Disease Consultants
-
Ledende efterforsker:
- Ashish Shah, MD
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Ledende efterforsker:
- Ashish Shah
-
Champaign, Illinois, Forenede Stater, 61822
- Rekruttering
- Christie Clinic
-
Kontakt:
- Andrew Bartlett
- Telefonnummer: 217-366-1331
- E-mail: abartlett@christieclinic.com
-
Champaign, Illinois, Forenede Stater, 61822
- Aktiv, ikke rekrutterende
- Christie Clinic
-
Chicago, Illinois, Forenede Stater, 60631
- Rekruttering
- GI Solutions of Illinois
-
Ledende efterforsker:
- Charles Berkelhammer, MD
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Ledende efterforsker:
- Charles Berkelhammer
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Downers Grove, Illinois, Forenede Stater, 60515
- Rekruttering
- Digestive Health Services
-
Ledende efterforsker:
- Charles Berkelhammer, MD
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Ledende efterforsker:
- Charles Berkelhammer
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Lake Barrington, Illinois, Forenede Stater, 60010
- Rekruttering
- Gastroenterology and Internal Medicine Specialists (GAIMS)
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Ledende efterforsker:
- Nicole Gentile
-
Ledende efterforsker:
- Nicole Gentile, MD
-
Libertyville, Illinois, Forenede Stater, 60048
- Rekruttering
- Northshore Center for Gastroenterology (NCG)
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: (708) 860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Ledende efterforsker:
- Nicole Gentile, MD
-
Oak Lawn, Illinois, Forenede Stater, 60453
- Rekruttering
- Southwest Gastroenterology (SWG)
-
Ledende efterforsker:
- Charles Berkelhammer, MD
-
Kontakt:
- Hussain Boxwalla
- Telefonnummer: 708-860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
Ledende efterforsker:
- Charles Berkelhammer
-
Kontakt:
- Hussain Boxwalla Chief Operating Officer/Owner
- Telefonnummer: (708) 860-7866
- E-mail: hboxwalla@avicennaclinical.com
-
-
Indiana
-
Munster, Indiana, Forenede Stater, 46321
- Rekruttering
- Center for Digestive Health
-
Kontakt:
- Amir Husain
- Telefonnummer: 630-605-1522
- E-mail: amir.husain@avicennaclinical.com
-
Ledende efterforsker:
- Navin Kumar, MD
-
-
Kansas
-
Hutchinson, Kansas, Forenede Stater, 67502
- Aktiv, ikke rekrutterende
- Hutchinson Clinic
-
-
Louisiana
-
Covington, Louisiana, Forenede Stater, 70433
- Rekruttering
- Northlake Gastroenterology Associates
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Gregory Mula
-
Hammond, Louisiana, Forenede Stater, 70403
- Rekruttering
- Northlake Gastroenterology Associates
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Gregory Mula
-
-
Maryland
-
Olney, Maryland, Forenede Stater, 20832
- Rekruttering
- Olney Medical Group
-
Kontakt:
- Jnanu Shahi
- Telefonnummer: 301-774-5260
- E-mail: jnanushrestha@yahoo.com
-
Ledende efterforsker:
- Gaurang Thaker, MD
-
-
Michigan
-
Bloomfield Township, Michigan, Forenede Stater, 48302
- Rekruttering
- Embassy Research Network
-
Kontakt:
- Zander Minano
- Telefonnummer: 248-622-4083
- E-mail: zminano@embassyresearch.com
-
Ledende efterforsker:
- Priyesh Patel, MD
-
Clarkston, Michigan, Forenede Stater, 48346
- Rekruttering
- Tanir Medical Center, PC
-
Kontakt:
- Reha Avci
- Telefonnummer: 248-620-3700
- E-mail: rehaavci@tanirmedicalcenter.com
-
Ledende efterforsker:
- Narin Tanir-Avci, MD
-
-
Mississippi
-
Ridgeland, Mississippi, Forenede Stater, 39157
- Rekruttering
- Quinn Healthcare, PLLC
-
Ledende efterforsker:
- Timothy Quinn, MD
-
Kontakt:
- Khadijra Lockwood
- Telefonnummer: 601-487-6482
- E-mail: Khadijra.lockwood@roviaclinical.com
-
-
New Jersey
-
Clifton, New Jersey, Forenede Stater, 07013
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Steven Gronowitz
-
Hackensack, New Jersey, Forenede Stater, 07601
- Aktiv, ikke rekrutterende
- Gastroenterology Associates of New Jersey
-
Montclair, New Jersey, Forenede Stater, 07042
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Steven Gronowitz
-
Ridgewood, New Jersey, Forenede Stater, 07450
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Steven Gronowitz
-
Wayne, New Jersey, Forenede Stater, 07470
- Rekruttering
- Gastroenterology Associates of New Jersey, LLC
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Steven Gronowitz
-
Wayne, New Jersey, Forenede Stater, 07470
- Aktiv, ikke rekrutterende
- Gastroenterology Associates of New Jersey
-
-
New York
-
Camillus, New York, Forenede Stater, 13031
- Rekruttering
- Associated Gastroenterologists of Central New York
-
Ledende efterforsker:
- John Sun
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
East Syracuse, New York, Forenede Stater, 13057
- Rekruttering
- Syracuse Gastroenterological Associates, P.C.
-
Ledende efterforsker:
- Dennis Reedy
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Fayetteville, New York, Forenede Stater, 13066
- Rekruttering
- Associated Gastroenterologists of Central New York
-
Ledende efterforsker:
- John Sun
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
New York, New York, Forenede Stater, 10010
- Rekruttering
- NYU Langone
-
Kontakt:
- Anika Zaman
- Telefonnummer: (212) 686-7500 ext 15745
- E-mail: anika.zaman@nyulangone.org
-
Ledende efterforsker:
- Peter Liang, MD
-
Orchard Park, New York, Forenede Stater, 14127
- Rekruttering
- Orchard Park Family Practice
-
Kontakt:
- Elizabeth Swanson
- Telefonnummer: 716-339-3666
- E-mail: swanson@circuitclinical.com
-
Ledende efterforsker:
- Richard Ruh
-
Valley Stream, New York, Forenede Stater, 11581
- Rekruttering
- GastroCare LI
-
Ledende efterforsker:
- Brandon Rieders
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Ledende efterforsker:
- Brandon Rieders, MD
-
-
North Carolina
-
Cary, North Carolina, Forenede Stater, 27518
- Rekruttering
- Cary Gastroenterology Associates
-
Ledende efterforsker:
- Michael Brody
-
Kontakt:
- Alan Bernegger
- Telefonnummer: 920-472-1093
- E-mail: abernegger@yanuvia.com
-
Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill
-
Ledende efterforsker:
- Sarah McGill, MD
-
Kontakt:
- Shilpa Karanjit
- Telefonnummer: 919-843-8519
- E-mail: shilpa_karanjit@med.unc.edu
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- University of North Carolina at Chapel Hill
-
Ledende efterforsker:
- Sarah McGill, MD
-
Kontakt:
- Shilpa Karanjit
- Telefonnummer: 919-843-8519
- E-mail: shilpa_karanjit@med.unc.edu
-
Hillsborough, North Carolina, Forenede Stater, 27278
- Rekruttering
- University of North Carolina at Chapel Hill
-
Ledende efterforsker:
- Sarah McGill, MD
-
Kontakt:
- Shilpa Karanjit
- Telefonnummer: 919-843-8519
- E-mail: shilpa_karanjit@med.unc.edu
-
Mocksville, North Carolina, Forenede Stater, 27028
- Aktiv, ikke rekrutterende
- Piedmont Healthcare, P.A.
-
Pinehurst, North Carolina, Forenede Stater, 28374
- Trukket tilbage
- Pinehurst Medical Clinic
-
Sanford, North Carolina, Forenede Stater, 27330
- Trukket tilbage
- Sanford Cardiology Pinehurst Medical Clinic
-
Statesville, North Carolina, Forenede Stater, 28625
- Aktiv, ikke rekrutterende
- Piedmont Healthcare LLC
-
-
Pennsylvania
-
Altoona, Pennsylvania, Forenede Stater, 16602
- Rekruttering
- US Digestive Health at Blair
-
Ledende efterforsker:
- Mitul Patel
-
Kontakt:
- Amanda Bianconi
- Telefonnummer: 3102 814-946-5469
- E-mail: abianconi@usdhealth.com
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania
-
Ledende efterforsker:
- Bryson Katona, MD
-
Kontakt:
- Alexis Winters
- Telefonnummer: 215-349-8222
- E-mail: alexis.winters@pennmedicine.upenn.edu
-
Pottstown, Pennsylvania, Forenede Stater, 19464
- Rekruttering
- Health Living at Pottstown Medical Specialists, Inc
-
Kontakt:
- Stacy Cowden
- Telefonnummer: 610-858-9174
- E-mail: scowden@circuitclinical.com
-
Ledende efterforsker:
- Wade Brosius
-
-
Texas
-
Austin, Texas, Forenede Stater, 78735
- Aktiv, ikke rekrutterende
- Premier Family Physicians
-
Austin, Texas, Forenede Stater, 78746
- Aktiv, ikke rekrutterende
- Premier Family Physicians
-
Garland, Texas, Forenede Stater, 75043
- Rekruttering
- Broadway Medical Clinic
-
Kontakt:
- Ana Goytia
- Telefonnummer: 972-240-8539
- E-mail: anaisagoytia2@gmail.com
-
Ledende efterforsker:
- Mohammed Al-Haider, MD
-
Houston, Texas, Forenede Stater, 77090
- Rekruttering
- Integrity Advanced Therapeutics, PLLC
-
Kontakt:
- Scott Ward
- Telefonnummer: 281-453-2005
- E-mail: scott.ward@iat.care
-
Ledende efterforsker:
- Howard Hamat
-
Paris, Texas, Forenede Stater, 75460
- Rekruttering
- Paris Family Physicians
-
Kontakt:
- Katie Stringer
- Telefonnummer: 903-785-4362
- E-mail: katiestringer00@yahoo.com
-
Ledende efterforsker:
- Alois Pauls, MD
-
Shenandoah, Texas, Forenede Stater, 77384
- Rekruttering
- Center for Digestive Disease
-
Ledende efterforsker:
- Shail Maheshwari
-
Kontakt:
- Melissa Clark
- Telefonnummer: 936-321-5440
- E-mail: melissa.clark@cddgastro.net
-
Tomball, Texas, Forenede Stater, 77375
- Rekruttering
- Horizon Clinical Research Group
-
Ledende efterforsker:
- Amar Dodda
-
Kontakt:
- Shatabdi Satpathi
- Telefonnummer: 281-803-9960
- E-mail: shatabdi@horizoncrg.com
-
Ledende efterforsker:
- Amar Dodda, MD
-
-
Virginia
-
Williamsburg, Virginia, Forenede Stater, 23188
- Rekruttering
- Tidewater Physician Multispecialty Group Clinical Research
-
Ledende efterforsker:
- Frances Jones
-
Kontakt:
- Gabrielle Land
- Telefonnummer: 757-707-3503
- E-mail: gabrielle.land@tpmgpc.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
-
Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
-
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 undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07-GI-003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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