Aún no reclutaNCT07924384Registro de ClinicalTrials.gov

Prognostic and Predictive Factors in Childhood Soft Tissue Sarcomas

Non-rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: Observacional
Fase: No aplica / no indicada
Rango de edad: No especificado - 25 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 150 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Población del estudio

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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No informado
Enmascaramiento: No informado

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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Histopathological profiling of NRSTS tumors

Plazo: 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

Plazo: 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.

Medidas secundarias

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

Plazo: 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

Plazo: 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.

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (28)

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Buscar un centro en este estudio

28 centros

Chr Felix GuyonSaint-Denis, La Réunion, FranceEstado desconocido

Yves REGUERRE, MDPRINCIPAL_INVESTIGATOR

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Población del estudio

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (28)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research