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Blood test could predict melanoma treatment failure

NCT ID NCT04866680

Knowledge-focused Sponsor: Institut de Cancérologie de Lorraine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 3 times

Summary

This study looks at whether analyzing tumor DNA in the blood can help monitor melanoma after surgery. Researchers will collect blood samples from 136 patients before and after surgery, and every 3-4 months, to see if changes in DNA levels predict when a treatment stops working. The goal is to find a simple way to detect resistance early, so doctors can adjust treatment sooner.

What this could mean

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

What this could lead to
If successful, this could lead to a blood test that helps doctors spot melanoma treatment resistance early, allowing quicker changes in therapy.
What could go wrong
This is an observational study, not a treatment trial. It may not prove that ctDNA monitoring improves outcomes, and results might not apply to all melanoma patients.

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

136 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Nov 2028

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: * Adult patient; * ECOG performance status 0-2; * Patient with melanoma stage IIB or IIC, or any stage III, or stage IV that has been resected or is resectable; * Treatment-naïve patient (except for initial excisional biopsy performed for diagnostic purposes); * Patient scheduled to receive adjuvant therapy within 12 weeks following surgery, consisting of anti-BRAF and anti-MEK kinase inhibitors or anti-PD-1 monoclonal antibody immunotherapy, in accordance with marketing authorization; * Patient with stage IIIB, IIIC, IIID, or IV melanoma with macroscopic lesions (clinically or radiologically detectable) eligible for neoadjuvant therapy, surgery, and adjuvant therapy (according to current recommendations: ESMO and NCCN guidelines, and treatment regimens from the SWOG S1801 and NADINA studies); * Biological parameters compatible with the planned treatment; * Patient informed and having provided written informed consent. Exclusion Criteria: * Patient with mucosal melanoma or choroidal (uveal) melanoma; * Patient with another synchronous malignancy or who has been treated for another malignancy within the 3 years preceding informed consent (except carcinoma in situ of the cervix or resected cutaneous carcinoma); * Contraindication to a 30 mL blood sample; * Contraindication to surgery; * Contraindication to the proposed medical treatment (anti-BRAF and anti-MEK targeted therapies or immunotherapy); * Patient participating in another clinical trial involving an investigational medicinal product; * Pregnant or breastfeeding woman; * Patient deprived of liberty (including those under legal guardianship or curatorship).

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Conditions

The condition(s) this trial relates to.

melanoma

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • CGFL

    Dijon, France

  • CHU Jean Minjoz

    Besançon, France

  • Chru Lille

    Lille, France

  • Chru Nancy

    Vandœuvre-lès-Nancy, France

  • Chu Dijon

    Dijon, France

  • Ghr Mulhouse Sud Alsace

    Mulhouse, France

  • Institut Godinot

    Reims, 51100, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

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