Clinical trial · Observational
Drug Sensitivity and Mutation Profiling
Drug Sensitivity Testing and Mutation Profiling in Childhood Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, non-randomized observational study. Freshly isolated tumor cells will be tested for chemosensitivity to the standard of care drugs as single agents and in combinations using state-of-the-art viability assay designed for ex-vivo high-throughput drug sensitivity testing (DST). In addition, the genetic profile of the tumor will be obtained from the medical records and correlated with drug response.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Sarcoma of Soft Tissue | Childhood Soft Tissue Sarcoma | ALIAS | 0.90 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma Rhabdoid | — | UNRESOLVED | — |
| Sarcoma, Spindle Cell | Spindle Cell Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Wilms Tumor | Wilms Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with newly diagnosed as well as relapsed/refractory sarcomas.
- description
- The investigators intend to enroll newly diagnosed or refractory/relapsed pediatric patients with all types of sarcomas where tumor tissue would be available for ex vivo drug screening and genomic profiling. This observational study will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes (response, survival, or relapse). The treating physician will decide which of the standard treatment options is appropriate independent of the DST results. The results of DST will not be available to the treating physician at the time of decision on the treatment regimen. DST will include all drugs from the standard treatment regimens available for all types of sarcomas
Primary outcomes (2)
- measure
- To correlate results of drug sensitivity and mutation profiles with clinical outcomes in response to therapy.
- timeFrame
- Up to 4 years
- description
- Response to therapy (RTT): an event of achieving "partial response" or "complete response" during the study period, based on the best response of the corresponding enrolled patient.
- measure
- To correlate results of drug sensitivity and mutation profiles with clinical outcomes in progression-free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 21 years or younger at the time of enrollment on this study of any gender, race, or ethnicity. * Subjects with suspected or confirmed diagnosis of all types of sarcomas. * Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers). * Subjects are willing to have a blood draw or buccal swab done for the purposes of genetic testing. * Subjects or their parents or legal guardians willing to sign informed consent. * Subjects aged 7 to 17 willing to sign assent. Exclusion Criteria: * Subjects who do not have malignant tissue available and accessible. * The amount of excised malignant tissue is not sufficient for ex vivo drug testing and/or genetic profiling. * Patients with other types of tumors and tumors that have a high (\>90%) cure rate with safe standard therapy.
References
Publications (0)
Data not yet available