Minimal Residual DiseaseTESTIMARNCT02400970
Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors
An observational study of Minimal Residual Disease and Fertility Preservation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Minimal Residual Disease, Fertility Preservation
- What is being tested?
- malignant cells
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients treated for a solid tumor during infancy
Who may be able to join
- Men in childbearing age whose fertility assessment require a testicular biopsy may be included
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Justyna KANOLD
About this study
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.
Read the 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.
- Conditions
- Minimal Residual Disease, Fertility Preservation
- Being tested
- malignant cells
- Keywords
- Polymerase Chain Reaction, fertility preservation
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
malignant cellsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
malignant cells about 1/10 *6 cells.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minimal Residual DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justyna KANOLD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400970
- Sponsor's protocol ID
- CHU-0230
- Acronym
- TESTIMAR
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2015
- Last updated
- 27 Mar 2015
- Results posted
- No
Publications
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.
PubMed 31744224
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Contamination of Testicle Tissue by RT-PCR in Children With Solid Tumors
- ClinicalTrials.gov ID
- NCT02400970
- Acronym / sponsor ID
- TESTIMAR / CHU-0230
- Conditions
- Minimal Residual Disease, Fertility Preservation
- Keywords
- Polymerase Chain Reaction, fertility preservation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients treated for a solid tumor during infancy
Key inclusion criteria (1 listed)
- Men in childbearing age whose fertility assessment require a testicular biopsy may be included
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| malignant cells | Other | – |
Primary outcome
malignant cells about 1/10 *6 cells.
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Derived from this study: PubMed 31744224Chaput 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justyna KANOLD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Residual Disease and Fertility Preservation, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malignant cells about 1/10 *6 cells. (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.