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

NCT04813627 | Completed

• 2 other identifiers: BNT000-001DRKS00025104
• Study Type: observational
• Target: 2,079
• Locations: 4 countries
• Sites: 74

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.

Conditions

Colorectal Cancer Stage II; Colorectal Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Transfer of participants from the BNT000-001 study to the BNT122-01 clinical trial

  4 weeks following Visit 1 (upon availability of ctDNA positivity status)

Study Arms (1)

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

Interventions

Regular blood sample collection for ctDNA assessment PROCEDURE

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

Participants with R0 resected Stage II (high risk) or Stage III CRC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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):
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• BioNTech SE: lead

Study Sites (74)

Ridley-Tree Cancer Center

California City, California, 93105, United States

Location

John Muir Clinical Research Center

Concord, California, 94520, United States

Location

Marin Cancer Care

Greenbrae, California, 94904, United States

Location

The Oncology Institute of Hope

Los Angeles, California, 90033, United States

Location

Rocky Mountain Cancer Centers - Denver Midtown

Denver, Colorado, 80218, United States

Location

Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur

Decatur, Illinois, 62526, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States

Location

USOR - New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45245, United States

Location

USOR - Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Texas Oncology - Austin

Austin, Texas, 78705, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78229, United States

Location

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Rockwood Cancer Treatment Center

Spokane, Washington, 99204, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

ZNA Campus Middelheim

Antwerp, 2020, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

VZW Algemeen Ziekenhuis KLINA

Brasschaat, 2930, Belgium

Location

Algemeen Ziekenhuis Sint-Lucas

Bruges, 8310, Belgium

Location

Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis)

Jette, 1090, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Centres Hospitaliers Jolimont

La Louvière, 7100, Belgium

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Clinique et Maternite Sainte-Elisabeth (CMSE)

Namur, 5000, Belgium

Location

Clinique Saint-Pierre d'ottignies (CSPO)

Ottignies, 1340, Belgium

Location

Algemeen Ziekenhuis (AZ) Glorieux

Ronse, 9600, Belgium

Location

Centre Hospitalier Regional, CHR

Verviers, 4800, Belgium

Location

Gemeinschaftspraxis Dr. med. B. Heinrich, Prof. M. Bangerter MD

Augsburg, 86150, Germany

Location

Charité Campus Mitte (CCM) - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitaetsklinikum St. Josef-Hospital Bochum

Bochum, 44791, Germany

Location

Medizinische Klinik III, Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Cancer Center Donauwoerth and Dachau

Donauwörth, 86609, Germany

Location

St. Johannes Hospital

Dortmund, 44137, Germany

Location

Asklepios MVZ Elmshorn

Elmshorn, 25335, Germany

Location

Centrum fuer Haematologie und Onkologie Bethanien

Frankfurt am Main, 60389, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt am Main, 60431, Germany

Location

Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung

Frankfurt am Main, 60488, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

Frankfurt am Main, 60590, Germany

Location

Studiengesellschaft BSF

Halle, 06108, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Haematologisch-Onkologische Praxis Eppendorf HOPE

Hamburg, 20249, Germany

Location

Asklepios Kliniken Nord

Hamburg, 22417, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

SLK-Kliniken Heilbronn GmbH

Heilbronn, 74078, Germany

Location

Staedtisches Krankenhaus Kiel gGmbH

Kiel, 24116, Germany

Location

Internistische Schwerpunktpraxis Hamatologie und Onkologie

Mainz, 55122, Germany

Location

Ze:ro Arztpraxen

Mannheim, 68165, Germany

Location

Klinikum der Universität München, Medizinische Klinik und Poliklinik III

München, 81377, Germany

Location

Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach

München, 81737, Germany

Location

Prosper Hospital

Recklinghausen, 45659, Germany

Location

Universitaetsmedizin Rostock

Rostock, 18057, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Asklepios Klinik Weissenfels

Weißenfels, 06667, Germany

Location

Helios Dr. Horst Schmidt Kliniken (HSK)

Wiesbaden, 65199, Germany

Location

Forschungszentrum Ruhr

Witten, 58455, Germany

Location

Complejo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

Location

Centro Oncologico Galicia

A Coruña, 15009, Spain

Location

Hospital Universitari Germans Trias - ICO Badalona

Badalona, 08916, Spain

Location

IOR- Instituto Quiron Dexeus

Barcelona, 08028, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital De Sant Joan Despi Moises Broggi

Barcelona, 08970, Spain

Location

Hospital General De Granollers

Granollers, 08402, Spain

Location

Hospital Sant Joan de Deu-Fundacio Althaia

Manresa, 08243, Spain

Location

Complejo Hospitalario de Orense

Ourense, 32005, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, 43204, Spain

Location

Corporacio Sanitaria Universitaria Parc Tauli

Sabadell, 08208, Spain

Location

Complejo Hospitalario Universitario De Santiago De Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Mutua de Terrassa

Terrassa, 08222, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood and tumor tissue samples collected for ctDNA assessment will be destroyed when subsequent clinical validity and/or bridging studies to support the validation of ctDNA assay are completed (where the samples are not exhausted). * Remaining biospecimens from a particular participant must be destroyed if the participant specifically requests that their archival specimens are destroyed upon their withdrawal from the study. * Remaining archival tissue blocks will be returned to the site upon request or no later than the time of final closure of the study database, whichever occurs first. For participants who are not eligible for enrollment in study BNT122-01, remaining archival tissue blocks will be returned to the site no later than 6 months after eligibility determination. * Remaining unused samples will be stored for a maximum of 5 years after the end of the study.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: July 2, 2021
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); DE (29); ES (16); BE (12)