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Classical Hodgkin LymphomaEURHOLYNCT07356882

European Project for ctDNA Detection as a Biomarker for Non-invasive Therapy Monitoring in Paediatric Classical Hodgkin Lymphoma

An observational study of Classical Hodgkin Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Classical Hodgkin lymphoma (cHL) accounts for 15% of all cases of cancer in children and adolescents and represents the first cause of cancer during adolescence. Combined multi-modal chemotherapy and modern radiation techniques have transformed cHL in a highly curable cancer. Read more about this study

Who is it for?
Any age
Conditions the study is for
Classical Hodgkin Lymphoma
How many people
400 participants
Where
1 siteFrance
Study dates
24 Nov 2025to Nov 2029
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Children and adolescents newly diagnosed with Hodgkin lymphoma treated in participating pediatric oncology centers. Patients will be enrolled at diagnosis and followed prospectively for relapse outcomes

Who may be able to join

  • Confirmed classical Hodgkin lymphoma (cHL)
  • Children and young adults under the age of 25 years old
  • Signature of informed consent by the patient and/or holders of parental authority (depending on the age of the patient)
  • Affiliation to a social security scheme or being beneficiary of such a scheme

Who cannot join

  • Previous treatment with chemotherapy or radiotherapy for another cancer
  • Pretreatment of Hodgkin lymphoma (except one treatment with corticosteroid for 7 to 10 days for large or compressive mediastinal tumors).
  • Diagnosis of nodular lymphocyte predominant Hodgkin lymphoma (NLPHL)
  • Other concomitant malignancies • Residence outside participating countries in for which long-term follow-up cannot be ensured

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mathieu SIMONIN, Medical Doctor contact

00 33 1 44 73 66 04

mathieu.simonin@aphp.fr

Fabrice JARDIN, Professor contact

+ 33 1 49 28 23 06

fabrice.jardin@chb.unicancer.fr

France1 site, 1 recruiting
  • Pediatric Hematology and Oncology Department

    Paris, 75012

    Mathieu SIMONIN, MD, mathieu.simonin@aphp.fr

    Fabrice JARDIN, Professor, + 33 1 49 28 23 06, fabrice.jardin@chb.unicancer.fr

    Recruiting

Other trials in France

About this study

Official title: Non-interventional Research Protocol Involving Human Participants

Classical Hodgkin lymphoma (cHL) accounts for 15% of all cases of cancer in children and adolescents and represents the first cause of cancer during adolescence. Combined multi-modal chemotherapy and modern radiation techniques have transformed cHL in a highly curable cancer. However, up to 10-15% of patients still experience recurrent or primary refractory disease. Thus, there is an unmet need for unravelling the underlying mechanisms of treatment failure and refractoriness in paediatric cHL. Further refinements of treatment strategy are still needed to improve treatment results both in relapse and refractory (R/R) patients and to reduce long-term morbidity and mortality treatment related. Therefore, two main objectives arise: to improve early detection of patients with a high relapse risk to potentially intensify the first line treatment and to better identify low risk patients to further reduce the treatment burden in this good-prognostic population. Initial disease stratification and long-term outcome predictions remain a challenging issue in the field. PET/CT is currently the reference imaging method for initial staging and improves detection of extra nodal disease. None of previous prognostic factors accurately identify patients who will respond adequately and therefore limit the ability to identify patients who should require treatment that is more intensive or new therapeutic approaches like immunotherapy. Taken together, these data emphasize a clear unmet need in the field of cHL. We aim to develop a biomarker tool, which could sharpen the initial risk stratification, improve the assessment of disease evaluation during the treatment and beyond and facilitate the detection of relapse. Over the past decade, as in other malignancies the potential of quantification of circulating tumour DNA (ctDNA) or liquid biopsy, in circulating cell-free DNA (cfDNA) that comprises DNA fragments released from apoptotic or necrotic cells into circulation, has emerged as a promising tool for diagnosis and exploration of the genetic landscape associated with HRS and for response evaluation. Experiences of ctDNA in cHL was first reported in adult cHL. These previous studies paved the way for ctDNA implementation in cHL. First, they contributed to confirm the feasibility to use ctDNA in the detection of tumor-associated mutation. Using paired samples of ctDNA and tumor DNA from HRS cells obtained by microdissection they confirmed the consistent correlation between these two methods. Second, they highlighted the potential role of ctDNA as a surrogate marker for tumor baseline assessment and more importantly for interim evaluation reporting an excellent correlation between the PET/CT result and the presence or the absence of ctDNA after 2 cycles of chemotherapy. Furthermore, Sobesky et al. previously reported that cured patients who were inconsistently judged as interim PET/CT-positive had a more than 2-log drop in ctDNA, whereas relapsing patients who were inconsistently judged as interim PET/CT negative had a less than 2-log drop in ctDNA. These data suggest that ctDNA could be a relevant adjunct to conventional PET/CT approach.

Read the detailed description

Despite significant advances in the management of classical Hodgkin lymphoma (cHL) in children and adolescents, a proportion of patients still relapse or exhibit primary refractory disease. This highlights a persistent limitation in current prognostic tools, particularly in identifying, at diagnosis or early during treatment, those at high risk of treatment failure. Existing stratification systems rely on clinical features and PET/CT imaging, which, although valuable, do not consistently differentiate between patients requiring intensification and those who could benefit from treatment de-escalation.

To address this unmet need, the use of circulating tumor DNA (ctDNA) as a non-invasive biomarker has emerged as a promising avenue. ctDNA analysis allows real-time molecular assessment of tumor dynamics, including mutation detection and disease burden, without requiring invasive tissue biopsies. In adult cHL, ctDNA has demonstrated feasibility, prognostic relevance, and strong correlation with PET/CT results during treatment. Its early kinetics may even outperform imaging in predicting treatment outcomes, particularly in discordant PET scenarios.

In pediatric cHL, ctDNA remains underexplored. The HOLY study, a French initiative nested within the EuroNet-PHL-C2 framework, was among the first to evaluate ctDNA detection in this population using a targeted panel of 18 recurrently mutated genes. Preliminary findings show a high mutation detection rate (~85%) in baseline plasma samples. Parallel efforts in Germany (PHL-ctDNA study) use a broader panel and an alternative detection method, offering a valuable opportunity for methodological comparison and data integration.

The current study proposes a binational collaborative approach involving France and Germany to:

  • Extend and harmonize ctDNA analyses in pediatric cHL;
  • Compare sequencing methodologies for sensitivity, specificity, and clinical concordance;
  • Integrate ctDNA dynamics with imaging and clinical outcomes to refine prognostic models.

This will culminate in a prospective trial using a unified NGS panel (~80 genes), informed by pooled retrospective analysis. ctDNA will be assessed at strategic timepoints to evaluate its added value in relapse prediction and risk-adapted therapy.

Ultimately, this work seeks to validate ctDNA as a central biomarker for early response assessment, molecular monitoring, and personalized treatment planning in pediatric cHL.

Keywords
Classical Hodgkin lymphoma, Pediatric oncology, Circulating tumor DNA (ctDNA), Liquid biopsy, Risk stratification, Minimal residual disease (MRD), Biomarker, Next-Generation Sequencing (NGS), Treatment response evaluation, Relapse prediction, PET/CT correlation
Medical subject headings
Neoplasm, Residual

What participants receive

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

Study groups in NCT07356882
Study groupRoleWhat they receive
Main CohortctDNA analysis at 4 timepoints during standard treatment

What is being measured

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

  1. Relapse-Free Survival (RFS) at 2 and 5 years based on ctDNA status at diagnosis

    Time from initial diagnosis to first relapse or death from any cause. Patients will be stratified by ctDNA status at diagnosis, including quantitative burden and mutation profiles.

    Measured: 2 years and 5 years

Secondary outcomes (4)
  1. Diagnostic performance of ctDNA after 1 cycle of chemotherapy

    Sensitivity, specificity, PPV and NPV of ctDNA detection compared to PET/CT metrics (deltaSUVmax, Deauville score).

    Measured: At Day 28 (post first OEPA cycle)

  2. Diagnostic performance of ctDNA after 2 cycles of chemotherapy

    Sensitivity, specificity, PPV and NPV of ctDNA detection compared to PET/CT metrics (deltaSUVmax, Deauville score).

    Measured: At Day 56 (post second OEPA cycle)

  3. Diagnostic performance of ctDNA at end of treatment

    Sensitivity, specificity, PPV and NPV of ctDNA detection at end of treatment compared to PET/CT evaluation.

    Measured: At treatment completion (approximately Month 6)

  4. Molecular landscape of ctDNA at relapse

    Mutation profiling of ctDNA in patients with relapsed/refractory cHL and analysis of association between mutation patterns and treatment outcome.

    Measured: Up to 5 years

Timeline

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

  1. First posted21 Jan 2026
  2. Study start24 Nov 2025
  3. Primary completionNov 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356882
Sponsor's protocol ID
APHP241626
Other IDs
IDRCB 2025-A01092-47
Acronym
EURHOLY
Status last verified
Jan 2026
First submitted
13 Jan 2026
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Classical Hodgkin Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Mathieu SIMONIN, Medical Doctor (00 33 1 44 73 66 04, mathieu.simonin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-Free Survival (RFS) at 2 and 5 years based on ctDNA status at diagnosis (time frame: 2 years and 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Jan 2026.

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