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Clinical Trials in France / NCT07141862
Recruiting Observational

Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method

NCT07141862 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Clermont-Ferrand
Phase
Observational
Started
2025-02-01
Last updated
2025-09-03

Condition(s) studied

NeuroblastomaEwing Sarcoma

Investigational drug(s) / intervention(s)

RT-qPCRddPCR

RT-qPCR: Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using RT-qPCR

ddPCR: Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using ddPCR

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Validation of residual disease detection of neuroblastoma and Ewing sarcoma by ddPCR in ovarian and testicular tissues. — From 02-2025 to 02-2026 for analysis of neuroblastoma; from 02-2026 to 12-2027 for analysis of Ewing sarcoma.
    Detection of the copy number of specific tumor genes: PHOX2B for neuroblastoma and EWSR1-FLI1 for Ewing sarcoma in ovarian and testicular tissues using ddPCR. Residual disease will be detected in ovarian and testicular tissues contaminated with increasing quantities of tumor cells (0, 5, 10, 20, and 100 tumor cells) from neuroblastoma (IMR-32) and Ewing sarcoma (RD-ES), as well as in ovarian and testicular tissues from prepubertal patients diagnosed and treated for neuroblastoma and Ewing sarcoma during infancy.

Trial sites (1)

FacilityCityRegionStatus
University hospital Clermont-Ferrand Auvergne Recruiting

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Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Recruiting

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Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas Recruiting
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Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) Recruiting
Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07141862 on ClinicalTrials.gov ↗ ← All trials in France