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Cryopreserved Ovarian Tissue Transplantation in Patients Who Have Survived Sarcomas and Hematological Tumors

ConditionsSarcomasHaematological Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

The study aims to test for the presence or absence of primary tumor-specific tumor markers in ovarian tissue. Therefore, there will be a first phase in which pathology-specific markers will be identified in the patients' diagnostic pathological material by histological, immunohistochemical, and molecular analysis; then, tumor markers will be sought in cryopreserved ovarian tissue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with Ewing (ES) and synovial (SS) sarcoma, acute lymphoblastic leukemia (LLA), acute myeloid leukemia (LMA), chronic myeloid leukemia (LMC) and myelodysplasia (MDS)

No objection to the procedure of sampling for cryopreservation or reimplantation of ovarian tissue by the patient's reference oncologist (according to PA105)

Obtaining informed consent.

Age >18 and under 38 at the time of cryopreservation

Disqualifiers

Contraindications to laparoscopy

HIV, hepatitis B and C, treponema pallidum and positive PAP tests

Malignant disease involving the ovary or samples to be reimplanted

Trial design

Design model

Parallel

Treatments tested in this trial

  • Step 1

    Other intervention

    Cryopreservation of ovarian tissue

  • Step 2

    Other intervention

    Analysis of tumor markers in the primary tumor

  • Step 3

    Other intervention

    Search for neoplastic cells in cryopreserved ovarian tissue

  • Step 4

    Other intervention

    Cryopreserved ovarian tissue autotransplantation

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Patients who request cryopreservation of ovarian tissueOther 3 interventions
Group B: Patients with already cryopreserved ovarian tissue at the criobankOther 2 interventions
Group C: Patients who request ovarian tissue reimplantationOther 3 interventions

Trial outcomes

Primary outcomes

1

Detection rate of cancer cells on cryopreserved ovarian tissue

Detection rate of cancer cells on cryopreserved ovarian tissue for a diagnostic panel specific to pathology in anamnesis, patients with Ewing sarcoma (SE), synovial sarcoma (SS), acute lymphoblastic leukemia (LLA), acute myeloid leukemia (AML), chronic myeloid leukemia (CML) or myelodysplasia (MDS)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Concordance of histological/molecular investigations

Establish the correlation between histological-immunohistochemicals investigations and molecular investigations and between molecular investigations in identifying neoplastic cells in cryopreserved ovarian tissue

Time frame
through study completion, an average of 1 year
2

Disease-specific detection rate

Identify the diagnostic method with the highest detection rate for each pathology analyzed, including histo-immunohistochemical investigations and molecular investigations

Time frame
through study completion, an average of 1 year
3

Ovarian contamination

Estimate, for molecular analysis methods, the proportion of ovarian contamination by cancer cells in different pathologies

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Source ClinicalTrials.gov
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