Clinical Trials Logo

Clinical Trial Summary

For prepubertal patients, cryopreservation of testicular tissue is the only option available to preserve their fertility before cancer treatment. But testicular autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the testicular tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of testicular tissue cryopreservation.


Clinical Trial Description

Some solid tumors have high risk of metastatic localization including in testis. There is concern over the possible presence of malignant cells in testicular tissue that could cause a recurrence of the primary disease after reimplantation. Thus, the possibility of testicular tissue involvement needs to be evaluated with sensitive molecular methods.

Based on our experience in detection by RT-PCR of minimal residual disease (MRD) in neuroblastoma since 1994 [Tchirkov et al. 2003] and in testicular tissue cryopreservation since 2012, we want to develop a specific and sensitive method for residual disease detection by RT-PCR in order to evaluate the tumor contamination of testicular harvested tissue.

Study population: We chose 3 models of pediatric solid tumors with high risk of metastases and which often require sterilizing treatments (chemo and/or radiotherapy): neuroblastoma, Ewing tumor and alveolar rhabdosarcoma. We will use four tumor cells lines: IMR32 and SK-NSH for neuroblastoma; RD-ES for Ewing tumor; RH-30 for rhabdosarcoma. We plan to use 20 fragments per line.

Study duration: 12 months Study design: Testicular tissue without known malignancy but with a condition warranting a biopsy (fertility assessment) will be harvested.

The harvested testicular cortex will be treated to recover all viable sperm and then, we use remaining tissue to be contaminated with tumor cells lines. Then, detection of the specific transcript will be done by RT-PCR in fresh tissue and after freeze/thaw. Total RNA will be extracted with the TRI-reagent and qRT-PCR will be performed using the "TaqMan" technology.

Primary endpoint: to reach a sensitivity about 1/106 cells. ;


Study Design

N/A


Related Conditions & MeSH terms


NCT number NCT02400970
Study type Observational
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Status Recruiting
Phase N/A
Start date November 2014
Completion date June 2016

See also
  Status Clinical Trial Phase
Terminated NCT04044560 - Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant Phase 2
Recruiting NCT05959720 - Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Active, not recruiting NCT02458014 - Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease Phase 2
Active, not recruiting NCT03233854 - CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Active, not recruiting NCT04853017 - A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Phase 1
Not yet recruiting NCT06358430 - Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) Phase 1
Not yet recruiting NCT05603156 - A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive N/A
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT05601830 - Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease Phase 1
Recruiting NCT06066905 - A Study of Chidamide With AZA in MRD Positive AML After Transplant N/A
Terminated NCT03272633 - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies Early Phase 1
Recruiting NCT03241940 - Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Completed NCT03096782 - Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma Phase 2
Completed NCT05093192 - Mobilising Tumour and Immune Cells Via Exercise in Chronic Lymphocytic Leukaemia N/A
Recruiting NCT06230185 - ctDNA Based MRD Testing for NAC Monitoring in TNBC
Recruiting NCT02400827 - Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors N/A
Active, not recruiting NCT01894477 - Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Phase 2
Active, not recruiting NCT04920188 - Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)
Completed NCT02714790 - Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia N/A