Fertility Preservation in Children With Neuroblastoma or Ewing's Sarcoma: Detection of Residual Disease by a Sensitive Method

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 45
View:

• 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.

Locations
Other Locations
France
University hospital
RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre
drci@chu-clermontferrand.fr
04 73 75 11 95
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 89
Treatments
Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using RT-qPCR
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.
Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using ddPCR.
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.
Sponsors
Leads: University Hospital, Clermont-Ferrand
Collaborators: University Hospital, Rouen

This content was sourced from clinicaltrials.gov