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

Sponsor
University Hospital, Clermont-Ferrand
Study ID
NCT07141862
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • RT-qPCR — DIAGNOSTIC_TEST
    Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using RT-qPCR
  • ddPCR — DIAGNOSTIC_TEST
    Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using ddPCR

Study Details

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.

Key Dates

First listed
Aug 26, 2025
Start date
Feb 1, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
89 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Validation of residual disease detection of neuroblastoma and Ewing sarcoma by ddPCR in ovarian and testicular tissues. [ Time Frame: From 02-2025 to 02-2026 for analysis of neuroblastoma; from 02-2026 to 12-2027 for analysis of Ewing sarcoma. ]

Central Contacts

Find similar trials

Nationwide
Neuroblastoma trialsOncology trialsPediatric oncology trials

Related Studies