Spots Global Cancer Trial Database for Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
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Trial Identification
Brief Title: Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
Official Title: Epidemiological Study to Determine the Prevalence of ctDNA Positivity in Participants With Stage II (High Risk) or Stage III CRC After Surgery With Curative (R0) Intent and Subsequent Adjuvant Chemotherapy With Monitoring of ctDNA During Clinical Follow-up
Study ID: NCT04813627
Interventions
Study Description
Brief Summary: This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of 630 days thereafter, according to CRC stages and disease characteristics. Participants receive no therapeutic intervention as part of this study. This study will identify participants who might be potential candidates for the clinical trial BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard AdCTx in this patient population. Based on the eligibility criteria for that trial, this study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection and are therefore at high risk of disease recurrence to enrich the BNT122-01 study cohort. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that trial if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from BNT000-001 will be carried across to the BNT122-01 trial where feasible.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ridley-Tree Cancer Center, California City, California, United States
John Muir Clinical Research Center, Concord, California, United States
Marin Cancer Care, Greenbrae, California, United States
The Oncology Institute of Hope, Los Angeles, California, United States
Rocky Mountain Cancer Centers - Denver Midtown, Denver, Colorado, United States
Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur, Decatur, Illinois, United States
Orchard Healthcare Research Inc., Skokie, Illinois, United States
USOR - New York Oncology Hematology, P.C., Albany, New York, United States
Oncology Hematology Care Clinical Trials, LLC, Cincinnati, Ohio, United States
USOR - Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Texas Oncology - Austin, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology - Northeast Texas, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Rockwood Cancer Treatment Center, Spokane, Washington, United States
Northwest Cancer Specialists, Vancouver, Washington, United States
ZNA Campus Middelheim, Antwerpen, , Belgium
Imelda Ziekenhuis, Bonheiden, , Belgium
VZW Algemeen Ziekenhuis KLINA, Brasschaat, , Belgium
Algemeen Ziekenhuis Sint-Lucas, Brugge, , Belgium
Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis), Jette, , Belgium
AZ Groeninge, Kortrijk, , Belgium
Centres Hospitaliers Jolimont, La Louvière, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, , Belgium
Clinique et Maternite Sainte-Elisabeth (CMSE), Namur, , Belgium
Clinique Saint-Pierre d'ottignies (CSPO), Ottignies, , Belgium
Algemeen Ziekenhuis (AZ) Glorieux, Ronse, , Belgium
Centre Hospitalier Regional, CHR, Verviers, , Belgium
Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD, Augsburg, , Germany
Charité Campus Mitte (CCM) - Universitätsmedizin Berlin, Berlin, , Germany
Universitaetsklinikum St. Josef-Hospital Bochum, Bochum, , Germany
Medizinische Klinik III, Universitätsklinikum Bonn, Bonn, , Germany
Cancer Center Donauwoerth and Dachau, Donauwoerth, , Germany
St. Johannes Hospital, Dortmund, , Germany
Asklepios MVZ Elmshorn, Elmshorn, , Germany
Centrum fuer Haematologie und Onkologie Bethanien, Frankfurt am Main, , Germany
Agaplesion Markus Krankenhaus, Frankfurt am Main, , Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung, Frankfurt am Main, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, Frankfurt am Main, , Germany
Studiengesellschaft BSF, Halle, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Haematologisch-Onkologische Praxis Eppendorf HOPE, Hamburg, , Germany
Asklepios Kliniken Nord, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
Internistische Schwerpunktpraxis Hamatologie und Onkologie, Mainz, , Germany
Ze:ro Arztpraxen, Mannheim, , Germany
Klinikum der Universität München, Medizinische Klinik und Poliklinik III, München, , Germany
Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach, München, , Germany
Prosper Hospital, Recklinghausen, , Germany
Universitaetsmedizin Rostock, Rostock, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Asklepios Klinik Weissenfels, Weißenfels, , Germany
Helios Dr. Horst Schmidt Kliniken (HSK), Wiesbaden, , Germany
Forschungszentrum Ruhr, Witten, , Germany
Complejo Hospitalario Universitario A Coruna, A Coruña, , Spain
Centro Oncologico Galicia, A Coruña, , Spain
Hospital Universitari Germans Trias - ICO Badalona, Badalona, , Spain
IOR- Instituto Quiron Dexeus, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital De Sant Joan Despi Moises Broggi, Barcelona, , Spain
Hospital General De Granollers, Granollers, , Spain
Hospital Sant Joan de Deu-Fundacio Althaia, Manresa, , Spain
Complejo Hospitalario de Orense, Orense, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Universitari Sant Joan de Reus, Reus, , Spain
Corporacio Sanitaria Universitaria Parc Tauli, Sabadell, , Spain
Complejo Hospitalario Universitario De Santiago De Compostela, Santiago De Compostela, , Spain
Hospital Universitario Mutua de Terrassa, Terrassa, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: BioNTech Responsible Person
Affiliation: BioNTech SE
Role: STUDY_DIRECTOR
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