Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors (TESTIMAR)
Primary Purpose
Minimal Residual Disease, Fertility Preservation
Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
malignant cells
Sponsored by
About this trial
This is an observational trial for Minimal Residual Disease focused on measuring Polymerase Chain Reaction, fertility preservation
Eligibility Criteria
Inclusion Criteria:
- Men in childbearing age whose fertility assessment require a testicular biopsy may be included
Exclusion Criteria:
-
Sites / Locations
- CHU Clermont-FerrandRecruiting
Outcomes
Primary Outcome Measures
malignant cells about 1/10 *6 cells.
Secondary Outcome Measures
Full Information
NCT ID
NCT02400970
First Posted
March 24, 2015
Last Updated
March 26, 2015
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02400970
Brief Title
Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors
Acronym
TESTIMAR
Official Title
Study About Contamination of Testicle Tissue by RT-PCR in Children With Solid Tumors
Study Type
Observational
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Residual Disease, Fertility Preservation
Keywords
Polymerase Chain Reaction, fertility preservation
7. Study Design
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
malignant cells
Primary Outcome Measure Information:
Title
malignant cells about 1/10 *6 cells.
Time Frame
at day 1
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men in childbearing age whose fertility assessment require a testicular biopsy may be included
Exclusion Criteria:
-
Study Population Description
patients treated for a solid tumor during infancy
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justyna KANOLD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Justyna KANOLD
12. IPD Sharing Statement
Citations:
PubMed Identifier
31744224
Citation
Chaput L, Greze V, Halle P, Radosevic-Robin N, Pereira B, Veronese L, Lejeune H, Durand P, Martin G, Sanfilippo S, Canis M, Kanold J, Tchirkov A, Brugnon F. Sensitive and Specific Detection of Ewing Sarcoma Minimal Residual Disease in Ovarian and Testicular Tissues in an In Vitro Model. Cancers (Basel). 2019 Nov 17;11(11):1807. doi: 10.3390/cancers11111807.
Results Reference
derived
Learn more about this trial
Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors
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