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Blood test may improve cancer care for colorectal and lung cancer patients

NCT ID NCT04258137

Knowledge-focused Sponsor: Institut Bergonié 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 2 times

Summary

This study is testing whether regular blood tests that look for tumor DNA (called liquid biopsy) can help doctors make better treatment decisions for people with advanced colorectal or lung cancer. About 332 participants will be randomly assigned to either receive standard imaging follow-up or imaging plus liquid biopsy. The goal is to see if the extra blood test information leads to longer survival.

What this could mean

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

Active substance
liquid biopsy (ctDNA)
What this could lead to
If successful, this could show that regular ctDNA testing helps doctors choose better treatments and monitor cancer more accurately, potentially improving survival.
What could go wrong
This is a phase 2 trial with a small number of participants, so results may not apply to all patients. The benefit of ctDNA over standard imaging is not yet proven.

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

About 332 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Age ≥ 18 years, 2. Histology: colorectal cancer, non-small cell lung cancer, 3. Locally advanced/unresectable and/or metastatic solid tumor, 4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1), 5. Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally \> 10 mm, 6. No previous systemic treatment for advanced disease, 7. Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose, 8. Eligible to first-line systemic therapy, 9. Patient with a social security in compliance with the French law, 10. Voluntary signed and dated written informed consent prior to any study specific procedure. Exclusion Criteria: 1. Inability to swallow, 2. Major problem with intestinal absorption, 3. Previous allogeneic bone marrow transplant, 4. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer, 5. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV), 6. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol, 7. Individuals deprived of liberty or placed under guardianship, 8. Pregnant or breast feeding women, 9. Previous enrolment in the present study, 10. Any contraindication to first-line systemic therapy.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

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

Colorectal cancer Non-small cell lung cancer

Contacts and locations

Locations

  • CHRU Brest

    Brest, 29200, France

  • Centre hospitalier de la Côte Basque

    Bayonne, 64109, France

  • Clinique Tivoli-Ducos

    Bordeaux, 33000, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077, France

  • Polyclinique Marzet

    Pau, 64000, France

More trials for these conditions

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