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Blood test may cut cancer diagnosis time

NCT ID NCT05846594

Diagnosis Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether using a liquid biopsy (a blood test that detects cancer DNA) early in the diagnostic process could help doctors diagnose and recommend treatment faster for people with advanced lung or gastrointestinal cancer. 463 participants were enrolled across multiple countries. The study compared the time to diagnosis and treatment recommendation between those who had the liquid biopsy alongside standard care versus standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FoundationOne® Liquid CDx Assay (a blood test that looks for cancer DNA)
What this could lead to
If successful, this could show that liquid biopsy helps doctors diagnose and recommend treatment for advanced cancer faster than traditional tissue biopsy alone.
What could go wrong
This is an observational study, not a treatment trial. It measures timing, not whether patients live longer or feel better. Results may not apply to all cancer types or settings.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

463 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2024

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.

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: * Participants presenting with a clinical diagnosis of advanced cancer, falling into one of the following two clinical presentations: i) De novo metastatic lung cancer as evidenced by imaging demonstrating a lung nodule/mass and objective evidence of a metastatic process; OR, ii) De novo metastatic gastrointestinal cancer as evidenced by imaging demonstrating a metastatic process in the abdomen/pelvis * Participants who are treatment naïve for the metastatic setting under study * Ability to comply with the study protocol * Participants must either: i) Have a tissue biopsy intended/planned to confirm malignant disease and histology; OR, ii) Have a tissue biopsy already performed but pathology has not yet been finalized. If a tissue biopsy has already been performed prior to ICF signature, then the subtyping of primary tumor may have already been assessed (i.e., for lung cancer TTF1, p40, and napsin A IHC staining may have already been performed). Exclusion Criteria: * Participants deemed not fit for treatment with systemic therapy * Participants deemed not fit for tissue biopsy * Participants with hematological neoplasm * Participants with primary malignant neoplasm of the brain * Participants with any previous molecular testing (NGS or other methods) e.g., all immunohistochemistry staining recommended by ESMO aiming to define the treatment decision (i.e., for lung cancer ALK, EGFR, and PD-L1 IHC staining must not have already been performed). Participants in which tissue biopsy and primary histotyping have been performed can be included in the study. * Prior treatment for metastatic cancer with the exception of participants who have already been diagnosed and treated for cancer, other than the cancer type under study, who have no evidence of relapse * History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm lung cancer lung carcinoma lung neoplasm metastatic malignant neoplasm

As listed by the trial registrant

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

Metastatic gastrointestinal cancer Metastatic lung cancer

Contacts and locations

Locations

  • Asklepios Klinik Gauting

    München-Gauting, 82131, Germany

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto, 37126, Italy

  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

    Udine, Friuli Venezia Giulia, 33100, Italy

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre Oscar Lambret

    Lille, 59000, France

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • Gustave Roussy

    Villejuif, 94800, France

  • Hopital Marie Lannelongue

    Le Plessis-Robinson, 92350, France

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014, Spain

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174, Germany

  • Klinikum der LMU München, Campus Großhadern, Krebszentrum München

    München, 81377, Germany

  • Med. Hochschule Hannover

    Hanover, 30625, Germany

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131, Italy

  • Universität Mannheim

    Mannheim, 68167, Germany

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246, Germany

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