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

NCT ID: NCT04813627

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2026-04-30

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 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.

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.

Conditions

Colorectal Cancer Stage II; Colorectal Cancer Stage III

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Regular blood sample collection for ctDNA assessment

Intervention Type: PROCEDURE

Blood samples for in vitro testing of ctDNA status will be drawn at study visits every 3 months for 21 months

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioNTech SE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BioNTech Responsible Person

Role: STUDY_DIRECTOR

BioNTech SE

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

Antwerp, , Belgium

Imelda Ziekenhuis

Bonheiden, , Belgium

VZW Algemeen Ziekenhuis KLINA

Brasschaat, , Belgium

Algemeen Ziekenhuis Sint-Lucas

Bruges, , 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

Donauwörth, , 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

Hanover, , Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, , Germany

Staedtisches Krankenhaus Kiel gGmbH

Kiel, , 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

Ourense, , 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

Countries

United States; Belgium; Germany; Spain

Other Identifiers

DRKS00025104

Identifier Type: OTHER

Identifier Source: secondary_id

BNT000-001

Identifier Type: -

Identifier Source: org_study_id