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Blood test hunts hidden cancer after surgery

NCT ID NCT04813627

Knowledge-focused Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked for leftover cancer DNA in the blood of over 2,000 people who had surgery for stage II or III colorectal cancer. Participants did not receive any new treatment—they just gave blood samples over about 21 months. The goal was to find patients who might be eligible for a future vaccine study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,079 people

The number who actually took part.

Started

Jul 2021

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer stage II Colorectal cancer stage III

Contacts and locations

Locations

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431, Germany

  • Algemeen Ziekenhuis (AZ) Glorieux

    Ronse, 9600, Belgium

  • Algemeen Ziekenhuis Sint-Lucas

    Bruges, 8310, Belgium

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Asklepios Klinik St. Georg

    Hamburg, 20099, Germany

  • Asklepios Klinik Weissenfels

    Weißenfels, 06667, Germany

  • Asklepios Kliniken Nord

    Hamburg, 22417, Germany

  • Asklepios MVZ Elmshorn

    Elmshorn, 25335, Germany

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

    Decatur, Illinois, 62526, United States

  • Cancer Center Donauwoerth and Dachau

    Donauwörth, 86609, Germany

  • Centre Hospitalier Regional, CHR

    Verviers, 4800, Belgium

  • Centres Hospitaliers Jolimont

    La Louvière, 7100, Belgium

  • Centro Oncologico Galicia

    A Coruña, 15009, Spain

  • Centrum fuer Haematologie und Onkologie Bethanien

    Frankfurt am Main, 60389, Germany

  • Charité Campus Mitte (CCM) - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Clinique Saint-Pierre d'ottignies (CSPO)

    Ottignies, 1340, Belgium

  • Clinique et Maternite Sainte-Elisabeth (CMSE)

    Namur, 5000, Belgium

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706, Spain

  • Complejo Hospitalario de Navarra

    Pamplona, 31008, Spain

  • Complejo Hospitalario de Orense

    Ourense, 32005, Spain

  • Corporacio Sanitaria Universitaria Parc Tauli

    Sabadell, 08208, Spain

  • Forschungszentrum Ruhr

    Witten, 58455, Germany

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

    Augsburg, 86150, Germany

  • Haematologisch-Onkologische Praxis Eppendorf HOPE

    Hamburg, 20249, Germany

  • Helios Dr. Horst Schmidt Kliniken (HSK)

    Wiesbaden, 65199, Germany

  • Hospital De Sant Joan Despi Moises Broggi

    Barcelona, 08970, Spain

  • Hospital General De Granollers

    Granollers, 08402, Spain

  • Hospital Sant Joan de Deu-Fundacio Althaia

    Manresa, 08243, Spain

  • Hospital Universitari Germans Trias - ICO Badalona

    Badalona, 08916, Spain

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Mutua de Terrassa

    Terrassa, 08222, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • IOR- Instituto Quiron Dexeus

    Barcelona, 08028, Spain

  • Imelda Ziekenhuis

    Bonheiden, 2820, Belgium

  • Internistische Schwerpunktpraxis Hamatologie und Onkologie

    Mainz, 55122, Germany

  • John Muir Clinical Research Center

    Concord, California, 94520, United States

  • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt am Main, 60590, Germany

  • Klinikum der Universität München, Medizinische Klinik und Poliklinik III

    München, 81377, Germany

  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung

    Frankfurt am Main, 60488, Germany

  • Marin Cancer Care

    Greenbrae, California, 94904, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medizinische Klinik III, Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684, United States

  • Oncology Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio, 45245, United States

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077, United States

  • Prosper Hospital

    Recklinghausen, 45659, Germany

  • Ridley-Tree Cancer Center

    California City, California, 93105, United States

  • Rockwood Cancer Treatment Center

    Spokane, Washington, 99204, United States

  • Rocky Mountain Cancer Centers - Denver Midtown

    Denver, Colorado, 80218, United States

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078, Germany

  • St. Johannes Hospital

    Dortmund, 44137, Germany

  • Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach

    München, 81737, Germany

  • Staedtisches Krankenhaus Kiel gGmbH

    Kiel, 24116, Germany

  • Studiengesellschaft BSF

    Halle, 06108, Germany

  • Texas Oncology - Austin

    Austin, Texas, 78705, United States

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology - Northeast Texas

    Tyler, Texas, 75702, United States

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78229, United States

  • The Oncology Institute of Hope

    Los Angeles, California, 90033, United States

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

    Albany, New York, 12206, United States

  • USOR - Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401, United States

  • Universitaetsklinikum St. Josef-Hospital Bochum

    Bochum, 44791, Germany

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • Universitaetsmedizin Rostock

    Rostock, 18057, Germany

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

    Jette, 1090, Belgium

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • VZW Algemeen Ziekenhuis KLINA

    Brasschaat, 2930, Belgium

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • ZNA Campus Middelheim

    Antwerp, 2020, Belgium

  • Ze:ro Arztpraxen

    Mannheim, 68165, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.