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Colorectal Cancer Stage IINCT04813627

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

An observational study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, run by BioNTech SE at 74 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Regular blood sample collection for ctDNA assessment
Type of treatment
Surgery or procedure
How many people
2,079 participants
Where
74 sitesin 4 countries
Study dates
2 Jul 2021to 23 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.

Trial locations and contacts

74 sites in 4 countries.

74 sites in 4 countries

Germany29 sites

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

    Augsburg, 86150

  • Charité Campus Mitte (CCM) - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitaetsklinikum St. Josef-Hospital Bochum

    Bochum, 44791

  • Medizinische Klinik III, Universitätsklinikum Bonn

    Bonn, 53127

  • Cancer Center Donauwoerth and Dachau

    Donauwörth, 86609

  • St. Johannes Hospital

    Dortmund, 44137

  • Asklepios MVZ Elmshorn

    Elmshorn, 25335

  • Centrum fuer Haematologie und Onkologie Bethanien

    Frankfurt am Main, 60389

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung

    Frankfurt am Main, 60488

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt am Main, 60590

  • Studiengesellschaft BSF

    Halle, 06108

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Haematologisch-Onkologische Praxis Eppendorf HOPE

    Hamburg, 20249

  • Asklepios Kliniken Nord

    Hamburg, 22417

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Staedtisches Krankenhaus Kiel gGmbH

    Kiel, 24116

  • Internistische Schwerpunktpraxis Hamatologie und Onkologie

    Mainz, 55122

  • Ze:ro Arztpraxen

    Mannheim, 68165

  • Klinikum der Universität München, Medizinische Klinik und Poliklinik III

    München, 81377

  • Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach

    München, 81737

  • Prosper Hospital

    Recklinghausen, 45659

  • Universitaetsmedizin Rostock

    Rostock, 18057

  • Universitaetsklinikum Ulm

    Ulm, 89081

  • Asklepios Klinik Weissenfels

    Weißenfels, 06667

  • Helios Dr. Horst Schmidt Kliniken (HSK)

    Wiesbaden, 65199

  • Forschungszentrum Ruhr

    Witten, 58455

Other trials in Germany

United States17 sites

  • USOR - New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Texas Oncology - Austin

    Austin, Texas, 78705

  • Ridley-Tree Cancer Center

    California City, California, 93105

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio, 45245

  • John Muir Clinical Research Center

    Concord, California, 94520

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

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

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Centers - Denver Midtown

    Denver, Colorado, 80218

  • USOR - Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Marin Cancer Care

    Greenbrae, California, 94904

  • The Oncology Institute of Hope

    Los Angeles, California, 90033

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78229

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Rockwood Cancer Treatment Center

    Spokane, Washington, 99204

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

Other trials in United States

Spain16 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Centro Oncologico Galicia

    A Coruña, 15009

  • Hospital Universitari Germans Trias - ICO Badalona

    Badalona, 08916

  • IOR- Instituto Quiron Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital De Sant Joan Despi Moises Broggi

    Barcelona, 08970

  • Hospital General De Granollers

    Granollers, 08402

  • Hospital Sant Joan de Deu-Fundacio Althaia

    Manresa, 08243

  • Complejo Hospitalario de Orense

    Ourense, 32005

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

  • Corporacio Sanitaria Universitaria Parc Tauli

    Sabadell, 08208

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

  • Hospital Universitario Mutua de Terrassa

    Terrassa, 08222

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Belgium12 sites

  • ZNA Campus Middelheim

    Antwerp, 2020

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • VZW Algemeen Ziekenhuis KLINA

    Brasschaat, 2930

  • Algemeen Ziekenhuis Sint-Lucas

    Bruges, 8310

  • Universitair Ziekenhuis Brussel (UZ-VUB - Academisch Ziekenhuis)

    Jette, 1090

  • AZ Groeninge

    Kortrijk, 8500

  • Centres Hospitaliers Jolimont

    La Louvière, 7100

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Clinique et Maternite Sainte-Elisabeth (CMSE)

    Namur, 5000

  • Clinique Saint-Pierre d'ottignies (CSPO)

    Ottignies, 1340

  • Algemeen Ziekenhuis (AZ) Glorieux

    Ronse, 9600

  • Centre Hospitalier Regional, CHR

    Verviers, 4800

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Regular blood sample collection for ctDNA assessment
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular blood sample collection for ctDNA assessmentProcedure or surgery

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

Study groups in NCT04813627
Study groupRoleWhat they receive
Participants with R0 resected Stage II (high risk) or Stage III CRCThe 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.
Receives: Procedure: Regular blood sample collection for ctDNA assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample

    Blood sample taken post-surgery and pre-adjuvant chemotherapy.

    Measured: 4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start2 Jul 2021
  3. Primary completion23 Apr 2025
  4. Study completion23 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,079 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813627
Sponsor's protocol ID
BNT000-001
Other IDs
DRKS00025104
Status last verified
May 2026
First submitted
17 Mar 2021
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer Stage II and Colorectal Cancer Stage III, run by BioNTech SE at 74 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Germany, United States, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample (time frame: 4 to 8 weeks (28 to 56 days) after surgery and within 7 days prior to start of AdCTx). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04813627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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