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Prognostic and Predictive Factors in Childhood Soft Tissue Sarcomas

Non-rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
Not specified - 25 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
150 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this study is to better understand biological characteristics of non-rhabdomyosarcoma soft tissue sarcomas (NRSTS), a rare group of cancers that affect children, adolescents, and young adults. Researchers also aim to identify factors that could help predict how the disease will behave and respond to treatment.

The main questions it aims to answer are:

  • Can advanced molecular analyses improve the classification and diagnosis of NRSTS?
  • Can blood- and tumor-based biomarkers help predict outcomes and detect relapse earlier?
  • Can researchers identify biological features that may guide future personalized treatments?

Participants aged 0 to 25 years with a recent diagnosis of NRSTS will take part in the prospective study. Researchers will collect archived tumor samples and blood samples during routine follow-up (approximately every 3 to 4 months) and will analyze these samples using advanced laboratory techniques. Clinical information will also be collected over a follow-up period of up to 4 years.

150 participants will be enrolled in the prospective part from 28 investigating centers across France.

Tumor samples already collected as part of your care, together with blood samples taken during follow-up visits, will be stored for future researches.

Read the full description

MAKI-France is an ambispective study. In addition to the 150 participants to include in the prospective part, 300 tumors collected as part of routine care will be analyzed.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Patients with local diagnosis of intermediate or malignant NRSTS, at the time of initial diagnosis only.
2. Localized or metastatic disease.
3. Age: 0-25 years.
4. Whatever strategy is decided (observation, surgery, chemotherapy, radiotherapy, other systemic therapies).
5. Within the 3 months after initial diagnosis.
6. Written informed consent from adult patients, or the 2 parents/legal representatives. Assent from minor patients should be verified.
7. Availability of archived tissue samples. Adult participants or parents must be willing to provide archival tissue. A minimum of 1 FFPE block / 1 HE slide with IHC slides available is required.
8. Patient affiliated to a health insurance system.

Exclusion Criteria:

1. NRSTS at relapse.
2. Any significant medical, psychological, social or geographic conditions that, in the opinion of the Investigator, would impair study participation or cooperation.
3. Patients deprived of their liberty or under guardianship.

Study population

Children and young adults (aged from 0 to 25 years) with a new diagnosis of NRSTS.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
NRSTS group

Single arm for all patients. Tumor samples will be taken for histological and molecular profiling, at baseline (FFPE for routine care or tissue sample from surgery. Blood samples will be taken at baseline and every 3- months up to end of study post surgery.

Other: Intervention

Intervention OTHER

Tumor samples will be taken for histological and molecular characterization at baseline (routine care biopsy) or surgery. Blood samples (liquid biopsies) will be taken at baseline and every 3-4 months up to end of study for early relapse detection

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Histopathological profiling of NRSTS tumors

Time frame: Baseline

Histopathological description of NRSTS tumors based on analysis of tumor tissue in paraffin. Results will be reported as the number and percentage of tumors classified into each histological subtype.

Molecular profiling of NRSTS tumors

Time frame: Baseline

Molecular profiling of NRSTS tumors combining DNA and RNA profiling, DNA methylation analysis, and clustering. Results will be reported as the number and percentage of tumors presenting identified molecular alterations.

Secondary measures

Percentage of patients with associated cfDNA and tumor tissue DNA methylation profiles in NRSTS

Time frame: Through study completion, an average of 4 years

Assessment of the association between DNA methylation profiles obtained from cell-free DNA (cfDNA) and matched tumor tissue DNA samples

Classification Accuracy of DNA Methylation-Based Classifiers for NRSTS Subtypes

Time frame: Baseline

Classification results for NRSTS subtypes obtained using the Institut Curie classifier based on DNA methylation and RNA profiling compared with those obtained using the Heidelberg classifier. Agreement in subtype classification and the distribution of classification results between the two classifiers will be reported.

Percentage of patients with detectable cfDNA molecular changes associated with disease status or relapse.

Time frame: Through study completion, an average of 4 years

Detection and characterization of prognostic and epigenetic biomarkers using cell-free DNA (cfDNA) analysis at initial diagnosis and during follow-up assessments performed every 3-4 months. Changes in cfDNA methylation profiles over time and their association with disease status and relapse will be reported, including the detection of molecular changes potentially indicative of relapse.

Identification of prognostic and predictive biomarkers a in NRSTS

Time frame: Through study completion, an average of 4 years

Sensitivity and specificity of molecular biomarkers, including epigenetic alterations at diagnosis and relapse, such as fragmentomic profiles and nucleosome positioning, genomic index, CINCARC, and other prognostic molecular signatures, compared with conventional clinical assessment and imaging.

Percentage of synovial sarcoma organoids showing similar histological and molecular profiles to their parental tumors

Time frame: At the time of surgical resection, up to 4 years

Assessment of the similarity between synovial sarcoma organoids and their corresponding parental tumor tissues based on histological and molecular characterization.

Impact of systematic national review on tumor diagnosis

Time frame: Baseline

Number and proportion of tumors with concordant diagnoses or diagnostic modifications following systematic pathological and molecular review at the National Reference Center in Lyon. Diagnostic modifications will be classified as minor, without significant clinical impact, or major, with clinical impact.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (28)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

28 locations

Chr Felix GuyonSaint-Denis, La Réunion, FranceStatus unknown
Yves REGUERRE, MDPRINCIPAL_INVESTIGATOR
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Chu AmiensAmiens, FranceStatus unknown
Antoine GOURMEL, MDPRINCIPAL_INVESTIGATOR
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Chu AngersAngers, FranceStatus unknown
Stéphanie PROUST, MDPRINCIPAL_INVESTIGATOR
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Chu BesanconBesançon, FranceStatus unknown
Victor PEREIRA, MDPRINCIPAL_INVESTIGATOR
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Chu PellegrinBordeaux, FranceStatus unknown
Jordane CHAIX, MDPRINCIPAL_INVESTIGATOR
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Chru BrestBrest, FranceStatus unknown
Liana CARAUSU, MDPRINCIPAL_INVESTIGATOR
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CHU CAENCaen, FranceStatus unknown
Marianna DEPARIS, MDPRINCIPAL_INVESTIGATOR
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Chu Clermont FerrandClermont-Ferrand, FranceStatus unknown
Pauline GIRARD-MONIN, MDPRINCIPAL_INVESTIGATOR
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Chu DijonDijon, FranceStatus unknown
Florent NEUMANN, MDPRINCIPAL_INVESTIGATOR
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Chu GrenobleGrenoble, FranceStatus unknown
Séverine BOBILLIER-CHAUMONT, MDPRINCIPAL_INVESTIGATOR
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Centre Oscar LambretLille, FranceStatus unknown
Anne-Sophie DEFACHELLES-THOMASSIN, MDPRINCIPAL_INVESTIGATOR
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Chu LimogesLimoges, FranceStatus unknown
Thomas LAUVRAY, MDPRINCIPAL_INVESTIGATOR
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IHOPe - CENTRE LEON BERARDLyon, FranceStatus unknown
Nadège CORRADINI, MDPRINCIPAL_INVESTIGATOR
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Chu La Timone - Hopital EnfantsMarseille, FranceStatus unknown
MDCONTACT
Angélique ROME, MDPRINCIPAL_INVESTIGATOR
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Chu MontpellierMontpellier, FranceStatus unknown
Study contactCONTACTNadege.corradini@ihope.fr
Stéphanie HAOUY, MDPRINCIPAL_INVESTIGATOR
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CHU Nantes - Hôpital Mère EnfantNantes, FranceStatus unknown
Study contactCONTACTNadege.corradini@ihope.fr
Morgane CLEIREC, MDPRINCIPAL_INVESTIGATOR
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CHU NICENice, FranceStatus unknown
Morgane PODROM, MDPRINCIPAL_INVESTIGATOR
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Institut CurieParis, FranceStatus unknown
Daniel ORBACH, MDPRINCIPAL_INVESTIGATOR
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Ap-Hp - Hopital TrousseauParis, FranceStatus unknown
Hélène BOUTROUX, MDPRINCIPAL_INVESTIGATOR
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CHU PoitiersPoitiers, FranceStatus unknown
Chrystelle DUPRAZ, MDPRINCIPAL_INVESTIGATOR
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Chu de Rennes - Hôpital SudRennes, FranceStatus unknown
Jamie PROBERT, MDPRINCIPAL_INVESTIGATOR
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Chu RouenRouen, FranceStatus unknown
Aude MARIE-CARDINE, MDPRINCIPAL_INVESTIGATOR
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Chu Saint EtienneSaint-Etienne, FranceStatus unknown
Marina GOUTTENOIRE, MDPRINCIPAL_INVESTIGATOR
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Chu Strasbourg - Hôpital HautepierreStrasbourg, FranceStatus unknown
Sarah JANNIER, MDPRINCIPAL_INVESTIGATOR
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Chu ToulouseToulouse, FranceStatus unknown
Marie-Pierre CASTEX, MDPRINCIPAL_INVESTIGATOR
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Chu Tours - Hôpital ClochevilleTours, FranceStatus unknown
Jill SERRE, MDPRINCIPAL_INVESTIGATOR
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CHU NANCY- Hôpital d'EnfantsVandœuvre-lès-Nancy, FranceStatus unknown
Ludovic MANSUY, MDPRINCIPAL_INVESTIGATOR
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Gustave RoussyVillejuif, FranceStatus unknown
Study contactCONTACT+33 1 42 11 60 5
Lucy METAYER, MDPRINCIPAL_INVESTIGATOR
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Study team and timeline

Lead sponsor
Institut Curie
Study start
2026-12 Estimated
Primary completion
2034-12 Estimated
Study completion
2034-12 Estimated
First posted
Nov 9, 2026 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

Official study title

Prognostic and Predictive Factors in Childhood Soft Tissue Sarcomas

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026