Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors (OVAMAR)
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:
- Women of any age, diagnosed with a benign cyst that needs a laparoscopy may be included
Exclusion Criteria:
-
Sites / Locations
- CHU de Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm Type
Arm Label
cryopreservation
Arm Description
Outcomes
Primary Outcome Measures
malignant cells about 1/10*6 cells.
Secondary Outcome Measures
Full Information
NCT ID
NCT02400827
First Posted
March 24, 2015
Last Updated
March 26, 2015
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02400827
Brief Title
Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors
Acronym
OVAMAR
Official Title
Study About Contamination of Ovarian 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 ovarian tissue is the only option available to preserve their fertility before cancer treatment. But ovarian 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 ovarian tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of ovarian tissue cryopreservation.
Detailed Description
Some solid tumors have high risk of metastatic localization including in ovaries. There is concern over the possible presence of malignant cells in ovarian tissue that could cause a recurrence of the primary disease after reimplantation. Thus, the possibility of ovarian tissue involvement needs to be evaluated with sensitive molecular methods. Those techniques are now available for leukaemia but histology is still the only way for solid tumors.
Based on our experience in detection by RT-PCR of minimal residual disease (MRD) in neuroblastoma since 1994 [Tchirkov et al. 2003] and in ovarian tissue cryopreservation since 1995 [Schubert et al. 2005, Chambon in press], we want to develop a specific and sensitive method for residual disease detection by RT-PCR in order to evaluate the tumor contamination of ovarian 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: Ovarian tissue without known malignancy but with a condition warranting laparoscopy (benign cysts) will be harvested during kystectomy (perikystic tissue).
The harvested ovarian cortex will be cut: one half will be frozen according to our routine protocol [Schubert et al. 2005] and the other half will 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
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryopreservation
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
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women of any age, diagnosed with a benign cyst that needs a laparoscopy 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 de 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
Learn more about this trial
Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors
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