Minimal Residual Disease Clinical Trial
Official title:
Study About Contamination of Testicle Tissue by RT-PCR in Children With Solid Tumors
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.
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.
;
N/A
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 |