MelanomaPERCIMELNCT04866680

Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

A study testing Personalized Circulating DNA follow-up in people with Melanoma, run by Institut de Cancérologie de Lorraine at 8 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: Personalized Circulating DNA follow-up
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 8 sitesFrance
Study dates: 31 Jan 2023to Nov 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

France8 sites

CHU Jean Minjoz
Besançon
CGFL
Dijon
Chu Dijon
Dijon
Chru Lille
Lille
Ghr Mulhouse Sud Alsace
Mulhouse
Institut Godinot
Reims, 51100
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Chru Nancy
Vandœuvre-lès-Nancy

Other trials in France

About this study

Official title: Personalized Circulating DNA Follow-up in Melanoma

PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.

Conditions: Melanoma
Being tested: Personalized Circulating DNA follow-up
Keywords: Circulating tumour DNA, immunotherapy, targeted therapy
Medical subject headings: Melanoma

What participants receive

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

Personalized Circulating DNA follow-upProcedure or surgery
FFPE tissue sample will be collected before and after surgery blood samples will be collected before and after surgery and every 3 to 4 months

Study groups in NCT04866680
Study group	Role	What they receive
Personalized Circulating DNA follow-up	Experimental	FFPE tissue sample + blood sample (20ml) Receives: Procedure: Personalized Circulating DNA follow-up

What is being measured

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

Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting
Measured: 24 months

Timeline

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

31 Jan 2023Nov 2028

First posted30 Apr 2021
Study start31 Jan 2023
Primary completionNov 2027 (estimated)
Study completionNov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MelanomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04866680
Sponsor's protocol ID: 2022-A01904-39
Acronym: PERCIMEL
Status last verified: Aug 2026
First submitted: 9 Mar 2021
Last updated: 1 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Geoffrois L, Harle A, Sahki N, Sikanja A, Granel-Brocard F, Hervieu A, Mortier L, Jeudy G, Michel C, Nardin C, Huin-Schohn C, Merlin JL. Personalized follow-up of circulating DNA in resected stage III/IV melanoma: PERCIMEL multicentric prospective study protocol. BMC Cancer. 2023 Jun 16;23(1):554. doi: 10.1186/s12885-023-11029-4.
PubMed 37328818

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Circulating DNA Follow-up in Melanoma
ClinicalTrials.gov ID: NCT04866680
Acronym / sponsor ID: PERCIMEL / 2022-A01904-39
Conditions: Melanoma
Keywords: Circulating tumour DNA, immunotherapy, targeted therapy
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 136 participants (actual)
Lead sponsor: Institut de Cancérologie de LorraineUniversity, hospital or other
Study start: 31 Jan 2023 (actual)
Primary completion: Nov 2027 (estimated)
Study completion: Nov 2028 (estimated)
First posted: 30 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Personalized Circulating DNA follow-up	Experimental	Procedure: Personalized Circulating DNA follow-upFFPE tissue sample + blood sample (20ml)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Personalized Circulating DNA follow-upFFPE tissue sample will be collected before and after surgery blood samples will be collected before and after surgery and every 3 to 4 months	Procedure or surgery	Personalized Circulating DNA follow-up

Primary outcome

Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
Time frame: 24 months
Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Background: PubMed 37328818Geoffrois L, Harle A, Sahki N, Sikanja A, Granel-Brocard F, Hervieu A, Mortier L, Jeudy G, Michel C, Nardin C, Huin-Schohn C, Merlin JL. Personalized follow-up of circulating DNA in resected stage III/IV melanoma: PERCIMEL multicentric prospective study protocol. BMC Cancer. 2023 Jun 16;23(1):554. doi: 10.1186/s12885-023-11029-4.
Individual participant dataSharing planned: No

Related trials for Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Circulating DNA follow-up in people with Melanoma, run by Institut de Cancérologie de Lorraine at 8 sites in France.

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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

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?

Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment (time frame: 24 months). 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 NCT04866680, which also lists 1 linked publication.

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 1 Sep 2026.