Clinical trial · Observational
Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method
Fertility Preservation in Children With Neuroblastoma or Ewing's Sarcoma: Detection of Residual Disease by a Sensitive Method
- 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)
In prepubertal patients, cryopreservation of ovarian or testicular tissue is currently the only available method for fertility preservation prior to gonadotoxic cancer treatments. However, this approach carries the risk of reintroducing malignant cells upon autotransplantation, particularly in cases of metastatic cancers such as neuroblastoma and Ewing sarcoma. Therefore, it is crucial to employ highly sensitive techniques to detect minimal residual disease (MRD) in preserved gonadal tissues. This study aims to identify the most effective detection method by comparing the sensitivity and specificity of reverse transcription quantitative PCR (RT-qPCR) and droplet digital PCR (ddPCR) in identifying MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues from patients treated for these malignancies during infancy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ddPCR | Diagnostic Test | — | UNRESOLVED |
| RT-qPCR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using RT-qPCR
- description
- First, the detection of minimal residual disease of neuroblastoma and Ewing sarcoma will be performed on an in vitro model that mimics the metastatic dissemination of these two solid tumors. Ovarian and testicular tissues will be contaminated with increasing quantities of tumor cells (0, 5, 10, 20, and 100 tumor cells) from neuroblastoma (IMR-32) and Ewing sarcoma (RD-ES). Then, the detection of MRD will be carried out on ovarian and testicular tissues from prepubertal patients diagnosed and treated for neuroblastoma and Ewing sarcoma during infancy. To detect this MRD in both models, the investigators will perform RNA extraction using TRIzol reagent, followed by reverse transcription and RT-qPCR to detect the specific tumor genes: PHOX2B for neuroblastoma and EWSR1-FLI1 for Ewing sarcoma.
- interventionNames
- Diagnostic Test: RT-qPCR
- label
- Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using ddPCR.
- description
- First, the detection of MRD of neuroblastoma and Ewing sarcoma will be performed on an in vitro model that mimics the metastatic dissemination of these two solid tumors. Ovarian and testicular tissues will be contaminated with increasing quantities of tumor cells (0, 5, 10, 20, and 100 tumor cells) from neuroblastoma (IMR-32) and Ewing sarcoma (RD-ES). Then, the detection of MRD will be carried out on ovarian and testicular tissues from prepubertal patients diagnosed and treated for neuroblastoma and Ewing sarcoma during infancy. To detect this MRD in both models, the investigators will perform RNA extraction using TRIzol reagent, followed by reverse transcription and ddPCR to detect the specific tumor genes: PHOX2B for neuroblastoma and EWSR1-FLI1 for Ewing sarcoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Women of any age diagnosed with a benign cyst requiring laparoscopy may be included. * Men of any age diagnosed with a non-obstructive azoospermia may be included. * Prepubertal girls and boys diagnosed with neuroblastoma or Ewing sarcoma during infancy may be included. * Capable of providing written informed consent to participate in the research study * Affiliated with a social welfare service. * For prepubertal patients, written informed consent to participate in the research study must be provided by their parents or legal guardians. Exclusion Criteria: * None
References
Publications (0)
Data not yet available