NCT07141862|Recruiting
Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method
PREFERPUBER
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PREFERPUBER
Sponsor study identifier
observational
89
1 country
1
Study Start
February 1, 2025
Actual (reported)Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2025
Actual (reported)August 19, 2025
Actual (reported)August 26, 2025
Actual (reported)June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Validation of residual disease detection of neuroblastoma and Ewing sarcoma by ddPCR in ovarian and testicular tissues.
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.
From 02-2025 to 02-2026 for analysis of neuroblastoma; from 02-2026 to 12-2027 for analysis of Ewing sarcoma.
Evaluation of the specificity and sensitivity of RT-qPCR and ddPCR for detecting residual disease of neuroblastoma and Ewing sarcoma 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.
Evaluation of the impact of ovarian tissue freezing protocols on RNA Quantity and Purity
From 02-2025 to 02-2026 for analysis of neuroblastoma; from 02-2026 to 12-2027 for analysis of Ewing sarcoma
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.
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.
Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using RT-qPCR
Detection of MRD of neuroblastoma and Ewing sarcoma in ovarian and testicular tissues using ddPCR
Residual disease detection will be conducted on ovarian and testicular tissues collected from prepubertal patients diagnosed and treated for neuroblastoma or Ewing sarcoma during infancy
University hospital
Clermont-Ferrand, Auvergne, 63000, France
Florence BRUGNON, MD, PhD, HDR
University Hospital, Clermont-Ferrand
First Submitted
August 19, 2025
First Posted
August 26, 2025
Study Start
February 1, 2025
Actual (reported)Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.
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Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 3, 2025
Record last verified: 2025-07
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