Prognostic and Predictive Factors in Childhood Soft Tissue Sarcomas
Non-rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)
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 screeningTreatment, 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
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.
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
Chu AmiensAmiens, FranceStatus unknown
Chu AngersAngers, FranceStatus unknown
Chu BesanconBesançon, FranceStatus unknown
Chu PellegrinBordeaux, FranceStatus unknown
Chru BrestBrest, FranceStatus unknown
CHU CAENCaen, FranceStatus unknown
Chu Clermont FerrandClermont-Ferrand, FranceStatus unknown
Chu DijonDijon, FranceStatus unknown
Chu GrenobleGrenoble, FranceStatus unknown
Centre Oscar LambretLille, FranceStatus unknown
Chu LimogesLimoges, FranceStatus unknown
IHOPe - CENTRE LEON BERARDLyon, FranceStatus unknown
Chu La Timone - Hopital EnfantsMarseille, FranceStatus unknown
Chu MontpellierMontpellier, FranceStatus unknown
CHU Nantes - Hôpital Mère EnfantNantes, FranceStatus unknown
CHU NICENice, FranceStatus unknown
Institut CurieParis, FranceStatus unknown
Ap-Hp - Hopital TrousseauParis, FranceStatus unknown
CHU PoitiersPoitiers, FranceStatus unknown
Chu de Rennes - Hôpital SudRennes, FranceStatus unknown
Chu RouenRouen, FranceStatus unknown
Chu Saint EtienneSaint-Etienne, FranceStatus unknown
Chu Strasbourg - Hôpital HautepierreStrasbourg, FranceStatus unknown
Chu ToulouseToulouse, FranceStatus unknown
Chu Tours - Hôpital ClochevilleTours, FranceStatus unknown
CHU NANCY- Hôpital d'EnfantsVandœuvre-lès-Nancy, FranceStatus unknown
Gustave RoussyVillejuif, FranceStatus unknown
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
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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
