Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors (OVAMAR)

March 26, 2015 updated by: University Hospital, Clermont-Ferrand

Study About Contamination of Ovarian Tissue by RT-PCR in Children With Solid Tumors.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand
        • Principal Investigator:
          • Justyna KANOLD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients treated for a solid tumor during infancy

Description

Inclusion Criteria:

  • Women of any age, diagnosed with a benign cyst that needs a laparoscopy may be included

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cryopreservation
Other: malignant cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
malignant cells about 1/10*6 cells.
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Justyna KANOLD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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