MyKids: molecular profiling of non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) in children, adolescents and young adults

MyKids: molecular identification and characterization of non-rhabdomyosarcoma soft tissue sarcoma in kids, adolescents and young adults: an EpSSG NRSTS study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12831761

Enrollment

250

Registered

2022-07-14

Start date

2022-09-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) Cancer

Interventions

At primary diagnosis, part of the biopsy material obtained for standard care will be used for the study (see primary outcome measures) and an additional tube of blood will be drawn for the study. Part

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients within 2 months after new diagnosis of NRSTS 2. Age 0 - 25 years 3. Written informed consent by parents/legal representatives and patients 12 year and older 4. Minimal requirements for study participation: diagnostic FFPE material for WP2 or fresh frozen sample for WP1

Exclusion criteria

Exclusion criteria: 1. Relapsed NRSTS, not included at diagnosis 2. No written informed consent

Design outcomes

Primary

Measure	Time frame
WP1 1. Gene expression changes, measured as expression score, by bulk mRNA sequencing at primary diagnosis. 2. Genetic alterations (e.g. copy number variations, SNVs, fusions, translocations), measured by Whole Exome Sequencing (WES) at primary diagnosis. 3. Epigenetic alterations (methylation patterns), measured by DNA Methylation profiling (DNAmeth) at primary diagnosis. 4. Comparison of diagnoses (diagnostic terms) established by before-mentioned molecular techinques to diagnoses established by conventional histology/pathology at primary diagnosis. WP2 5. Molecular diagnosis on FFPE material (gene expression changes, measured as expression score) by mRNA sequencing at primary diagnosis. 6. Genomic index, measured as comparative gene expression signature, by Comparative Genome Hybridization (aGCH) at primary diagnosis. 7. Fédération Nationale des Centers de Lutte Contre le Cancer (FNCLCC) grading, determined by pathological grading at primary diagnosis. 8. CINSARC signature (a 67-gene signature related to chromosome integrity and genome complexity) - detection by comparing prognostic value compared to CINSARC and pathological grading at primary diagnosis. WP3 9. Percentage of successful tumoroid models cultured (tumoroid culture successful or not) by basic mathematic analysis (percentages) at primary diagnosis. 10. Single cell mRNA sequencing of tumoroids (comparison of gene expression profiles between single cells and clustering into sub-populations) at primary diagnosis. WP4 11. Identification of possible patient specific, individually expressed ctDNA markers, by data analysis of molecular diagnostics on FFPE material and peripheral blood samples (DNA methylation profiling, WES, copy number profiling, assessment of patient specific breaking points) at primary diagnosis. 12. ctDNA marker measurement (e.g. DNA methylation profiling, WES, copy number profiling, assessment of patient specific breaking points) in peripheral blood at primary diagnosis, during treat	—

Measure

Time frame

WP1 1. Gene expression changes, measured as expression score, by bulk mRNA sequencing at primary diagnosis. 2. Genetic alterations (e.g. copy number variations, SNVs, fusions, translocations), measured by Whole Exome Sequencing (WES) at primary diagnosis. 3. Epigenetic alterations (methylation patterns), measured by DNA Methylation profiling (DNAmeth) at primary diagnosis. 4. Comparison of diagnoses (diagnostic terms) established by before-mentioned molecular techinques to diagnoses established by conventional histology/pathology at primary diagnosis. WP2 5. Molecular diagnosis on FFPE material (gene expression changes, measured as expression score) by mRNA sequencing at primary diagnosis. 6. Genomic index, measured as comparative gene expression signature, by Comparative Genome Hybridization (aGCH) at primary diagnosis. 7. Fédération Nationale des Centers de Lutte Contre le Cancer (FNCLCC) grading, determined by pathological grading at primary diagnosis. 8. CINSARC signature (a 67-gene signature related to chromosome integrity and genome complexity) - detection by comparing prognostic value compared to CINSARC and pathological grading at primary diagnosis. WP3 9. Percentage of successful tumoroid models cultured (tumoroid culture successful or not) by basic mathematic analysis (percentages) at primary diagnosis. 10. Single cell mRNA sequencing of tumoroids (comparison of gene expression profiles between single cells and clustering into sub-populations) at primary diagnosis. WP4 11. Identification of possible patient specific, individually expressed ctDNA markers, by data analysis of molecular diagnostics on FFPE material and peripheral blood samples (DNA methylation profiling, WES, copy number profiling, assessment of patient specific breaking points) at primary diagnosis. 12. ctDNA marker measurement (e.g. DNA methylation profiling, WES, copy number profiling, assessment of patient specific breaking points) in peripheral blood at primary diagnosis, during treat

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Argentina, Australia, Belgium, Czech Republic, Denmark, France, Greece, Israel, Italy, Netherlands, Norway, Portugal, Slovakia, Slovenia, Spain, Switzerland, United Kingdom

Contacts

Public ContactMiriam Stumpf

M.K.Stumpf@prinsesmaximacentrum.nl+31 88 97 272 72

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026