Меню
Идёт набор NCT06829654

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

Без фазы С лечением Sarcomas Haematological Malignancies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Step 1, Step 2, Step 3, Step 4.
Кому может быть актуально
Состояния в реестре: Sarcomas, Haematological Malignancies. Базовые параметры: 18 лет — 38 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Safety Assessment Of Cryopreserved Ovarian Tissue Transplantation In Patients Who Have Survived Sarcomas And Hematological Tumors

Обзор

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.

Подробное описание

Standardized strategies for detecting neoplastic cells in ovarian tissue of patients with prior sarcomas or oncohematologic malignancies are not available. To increase the safety of ovarian tissue transplantation, the use of advanced and highly sensitive molecular approaches could greatly improve the detection of malignant cells in ovarian tissue.

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.

Identifying highly sensitive molecular tests would lead to increased safety of transplantation in patients cured of sarcomas and oncohematologic diseases. Overall, applications of the techniques under study would increase the chances of resolving infertility, which often reduces the quality of life of these patients, by offering them the chance to procreate and have biological children. The hope of motherhood is an important psychological support and can greatly help patients cope with the difficult treatment process while minimizing social/psychological support. In the long journey of treatment to defeat the disease, being able to offer an option to at least combat the fear of losing endocrine and reproductive function can have a profound impact not only on the patients themselves, but on the entire family and non-family environment.

Вмешательства

  • Другое Step 1
    Cryopreservation of ovarian tissue
  • Другое Step 2
    Analysis of tumor markers in the primary tumor
  • Другое Step 3
    Search for neoplastic cells in cryopreserved ovarian tissue
  • Другое Step 4
    Cryopreserved ovarian tissue autotransplantation

Первичные конечные точки

  • Detection rate of cancer cells on cryopreserved ovarian tissue [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (3)
  • Concordance of histological/molecular investigations [Срок оценки: through study completion, an average of 1 year]
  • Disease-specific detection rate [Срок оценки: through study completion, an average of 1 year]
  • Ovarian contamination [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

For all groups:

  • 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.

Group 1:

  • Age >18 and under 38 at the time of cryopreservation
  • Request for cryopreservation of ovarian tissue at the Laboratory Cryopreservation Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO

Group 2:

  • Age >18 years
  • Ovarian tissue already collected and cryopreserved at the Laboratory for Cryopreservation of Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO

Group 3

  • Age > 18 years
  • Request for reimplantation of cryopreserved ovarian tissue at the Laboratory for Cryopreservation of Ovarian Tissue and Cell Cultures/Criobank IRCCS AOUBO
  • Early menopause or menstrual irregularities

Критерии исключения

Group 1 and 3

  • Contraindications to laparoscopy
  • HIV, hepatitis B and C, treponema pallidum and positive PAP tests
  • Malignant disease involving the ovary or samples to be reimplanted

Group 2 None.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Италия · 1 центр
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Идентификаторы

NCT: NCT06829654 · CRIOTESOVA2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗