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

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

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 up to 630 days (21 months) thereafter, according to CRC stages and disease characteristics.

Participants receive no therapeutic intervention as part of this study. This study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection who might be potential candidates for the clinical study BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard adjuvant chemotherapy in this patient population. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that study if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from this study (BNT000-001) will be carried across to the BNT122-01 study where feasible.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Stage II; Colorectal Cancer Stage III
• Intervention / Treatment: Procedure: Regular blood sample collection for ctDNA assessment

Detailed Description

Individual participants will be involved in the study for at least 12 months to up to 29 months (maximum follow-up 21 months after completion of AdCTx [Visit 10]). For all participants who transfer to BNT122-01 (NCT04486378), study participation in BNT000-001 will end at time of screening for BNT122-01.

• Study Type: Observational
• Enrollment (Actual): 2079

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Campus Middelheim
  • Bonheiden, Belgium, 2820
    • Imelda Ziekenhuis
  • Brasschaat, Belgium, 2930
    • VZW Algemeen Ziekenhuis KLINA
  • Bruges, Belgium, 8310
    • Algemeen Ziekenhuis Sint-Lucas
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis)
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • La Louvière, Belgium, 7100
    • Centres Hospitaliers Jolimont
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Namur, Belgium, 5000
    • Clinique et Maternite Sainte-Elisabeth (CMSE)
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre d'ottignies (CSPO)
  • Ronse, Belgium, 9600
    • Algemeen Ziekenhuis (AZ) Glorieux
  • Verviers, Belgium, 4800
    • Centre Hospitalier Regional, CHR
• Germany
  • Augsburg, Germany, 86150
    • Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD
  • Berlin, Germany, 10117
    • Charité Campus Mitte (CCM) - Universitätsmedizin Berlin
  • Bochum, Germany, 44791
    • Universitaetsklinikum St. Josef-Hospital Bochum
  • Bonn, Germany, 53127
    • Medizinische Klinik III, Universitätsklinikum Bonn
  • Donauwörth, Germany, 86609
    • Cancer Center Donauwoerth and Dachau
  • Dortmund, Germany, 44137
    • St. Johannes Hospital
  • Elmshorn, Germany, 25335
    • Asklepios MVZ Elmshorn
  • Frankfurt am Main, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Frankfurt am Main, Germany, 60389
    • Centrum fuer Haematologie und Onkologie Bethanien
  • Frankfurt am Main, Germany, 60488
    • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung
  • Frankfurt am Main, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
  • Halle, Germany, 06108
    • Studiengesellschaft BSF
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 20249
    • Haematologisch-Onkologische Praxis Eppendorf HOPE
  • Hamburg, Germany, 22417
    • Asklepios Kliniken Nord
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heilbronn, Germany, 74078
    • SLK-Kliniken Heilbronn GmbH
  • Kiel, Germany, 24116
    • Staedtisches Krankenhaus Kiel gGmbH
  • Mainz, Germany, 55122
    • Internistische Schwerpunktpraxis Hamatologie und Onkologie
  • Mannheim, Germany, 68165
    • Ze:ro Arztpraxen
  • München, Germany, 81377
    • Klinikum der Universität München, Medizinische Klinik und Poliklinik III
  • München, Germany, 81737
    • Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach
  • Recklinghausen, Germany, 45659
    • Prosper Hospital
  • Rostock, Germany, 18057
    • Universitaetsmedizin Rostock
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
  • Weißenfels, Germany, 06667
    • Asklepios Klinik Weissenfels
  • Wiesbaden, Germany, 65199
    • Helios Dr. Horst Schmidt Kliniken (HSK)
  • Witten, Germany, 58455
    • Forschungszentrum Ruhr
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • A Coruña, Spain, 15009
    • Centro Oncologico Galicia
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias - ICO Badalona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08970
    • Hospital de Sant Joan Despi Moises Broggi
  • Barcelona, Spain, 08028
    • IOR- Instituto Quiron Dexeus
  • Granollers, Spain, 08402
    • Hospital General de Granollers
  • Manresa, Spain, 08243
    • Hospital Sant Joan de Deu-Fundacio Althaia
  • Ourense, Spain, 32005
    • Complejo Hospitalario de Orense
  • Pamplona, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Reus, Spain, 43204
    • Hospital Universitari Sant Joan de Reus
  • Sabadell, Spain, 08208
    • Corporacio Sanitaria Universitaria Parc Tauli
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago de Compostela
  • Terrassa, Spain, 08222
    • Hospital Universitario Mutua de Terrassa
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• United States
  • California
    • California City, California, United States, 93105
      • Ridley-Tree Cancer Center
    • Concord, California, United States, 94520
      • John Muir Clinical Research Center
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care
    • Los Angeles, California, United States, 90033
      • The Oncology Institute of Hope
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers - Denver Midtown
  • Illinois
    • Decatur, Illinois, United States, 62526
      • Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
  • New York
    • Albany, New York, United States, 12206
      • USOR - New York Oncology Hematology, P.C.
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Oncology Hematology Care Clinical Trials, LLC
  • Oregon
    • Eugene, Oregon, United States, 97401
      • USOR - Willamette Valley Cancer Institute and Research Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology - Austin
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • San Antonio, Texas, United States, 78229
      • Texas Oncology - San Antonio Medical Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Northeast Texas
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Spokane, Washington, United States, 99204
      • Rockwood Cancer Treatment Center
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants with Stage II (high risk)/III CRC after resection (R0) and that are scheduled to receive AdCTx will be enrolled in this study.

Description

Inclusion Criteria:

• Must have given informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Age ≥ 18 years old at time of signing the informed consent form.
• Ability to comply with the study protocol, in the investigator's judgment.

• Must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as (any of):

  • T4
  • Grade ≥ 3
  • Clinical presentation with bowel obstruction or perforation
  • Histological signs of vascular, lymphatic or perineural invasion
  • < 12 nodes examined
• Adequate tumor material in formalin-fixed paraffin embedded blocks or as sectioned tissue (only upon approval by sponsor) must be available, preferably from resection. The specimen should be submitted along with an associated pathology report. Multiple samples may be provided as available, but priority should be given to tissue with the highest tumor content and lowest necrotic area.
• Intention to receive a standard of care AdCTx within 8 weeks post-surgery, and be scheduled for at least 3 months of treatment (including rest days) according to the treating physician or investigator.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Adequate end-organ function.

Exclusion Criteria:

• Neo-adjuvant (radio)chemotherapy prior to surgery.
• Prior systemic investigational therapy.
• Active Hepatitis B virus (HBV) infection.
• Active hepatitis C virus (HCV) infection.
• History of human immunodeficiency virus (HIV) antibody positivity.
• Residual tumor classification following surgery other than R0 (microscopic margin-negative resection).

• Participants with known past or current malignancy other than inclusion diagnosis, except for:

  • Cervical carcinoma of Stage 1B or less.
  • Non-invasive basal cell or squamous cell skin carcinoma.
  • Non-invasive, superficial bladder cancer.
  • Prostate cancer with a current prostate-specific antigen level < 0.1 ng/mL.
  • Any curable cancer with a complete response of > 2 years duration.
• Participant has not started standard of care AdCTx within 8 weeks post-surgery.
• Participant has received less than 3 months (including rest days) of AdCTx treatment.
• Inadequate tumor material (either quality or quantity) to support ctDNA analysis.
• Participants who have had prior splenectomy.
• Participants with diagnosed microsatellite instability high tumors.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with R0 resected Stage II (high risk) or Stage III CRC; The participants eligible for this epidemiological study are those with completely resected Stage II (high risk)/III CRC (per the American Joint Committee on Cancer [AJCC] 8th revised edition staging system) due to receive standard of care chemotherapy for at least 3 months following surgery.	Procedure: Regular blood sample collection for ctDNA assessment; Blood samples for in vitro testing of ctDNA status will be drawn at study visits every 3 months for 21 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample	Blood sample taken post-surgery and pre-adjuvant chemotherapy.	4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial	The absolute and relative frequency of participants that will transfer to the BNT122-01 clinical trial from this epidemiological study will be reported.	4 weeks following Visit 1 (upon availability of ctDNA positivity status)

Collaborators and Investigators

• Sponsor: BioNTech SE
• Investigators: Study Director: BioNTech Responsible Person, BioNTech SE

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): April 23, 2026

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BNT000-001; DRKS00025104 (Other Identifier: Deutsches Register Klinischen Studien (German Clinical Trials Register))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No