Detecting cancer cells in frozen ovarian or testicular tissue from children with neuroblastoma or Ewing sarcoma
Fertility Preservation in Children With Neuroblastoma or Ewing's Sarcoma: Detection of Residual Disease by a Sensitive Method
This project will test whether RT-qPCR or droplet digital PCR (ddPCR) better detects leftover neuroblastoma or Ewing sarcoma cells in frozen ovarian or testicular tissue from children treated during infancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 89 (estimated) |
| Ages | 2 Years to 45 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Clermont-Ferrand, Auvergne) |
| Trial ID | NCT07141862 on ClinicalTrials.gov |
What this trial studies
This observational study compares two molecular tests, RT-qPCR and droplet digital PCR (ddPCR), for detecting minimal residual disease of neuroblastoma and Ewing sarcoma in cryopreserved ovarian and testicular tissue. Tissue samples will be collected and analyzed at the University Hospital Clermont-Ferrand, including samples from prepubertal patients diagnosed in infancy and control tissues from adults undergoing benign procedures. Each sample will be examined with both methods to compare analytical sensitivity and specificity for tumor-specific markers. The findings will help determine which method more reliably identifies rare tumor cells that could cause relapse if gonadal tissue is later transplanted.
Who should consider this trial
Good fit: Ideal candidates are prepubertal girls and boys diagnosed with neuroblastoma or Ewing sarcoma during infancy who have cryopreserved ovarian or testicular tissue and whose parents or guardians can provide consent.
Not a fit: Patients without preserved gonadal tissue or whose tumors lack the molecular markers targeted by the assays are unlikely to benefit directly from this study.
Why it matters
Potential benefit: If successful, the work could make fertility restoration safer by identifying contaminated gonadal tissue and helping clinicians avoid reimplanting samples that contain tumor cells.
How similar studies have performed: Molecular MRD detection using RT-qPCR and ddPCR has shown success in blood and bone marrow for some pediatric cancers, but direct comparison of these methods in cryopreserved gonadal tissue for neuroblastoma and Ewing sarcoma is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand, Auvergne
- University hospital — Clermont-Ferrand, Auvergne, France (Recruiting)
Study contacts
- Principal investigator: Florence BRUGNON, MD, PhD, HDR — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: drci@chu-clermontferrand.fr
- Phone: 04 73 75 11 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.