Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Immunohistochemistry.
- Кому может быть актуально
- Состояния в реестре: Cancer of Cervix, Apoptosis. Базовые параметры: от 18 лет · Женщины.
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- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
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Официальное название
Evaluation of the Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on the 24-month Recurrence Rate in Locally Advanced Cervical Cancer
Обзор
Overexpression of inhibitors of apoptosis proteins (IAPs) in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy may have a prognostic role on the local recurrence rate at 24 months.
Подробное описание
Cervical cancer remains one of the most common cancers in women in terms of both incidence and mortality. Human Papilloma Virus carriage is a necessary condition for the development of these cancers but is not the only factor responsible for malignant transformation. Numerous molecular alterations come into play in the development of these tumours, involving the activation of oncogenes or the inactivation of tumour suppressor genes. Treatment of locally-advanced cancer is based on radiotherapy or a combination of radiotherapy and chemotherapy. Responses to anti-neoplastic treatments remain very heterogeneous from one woman to another. Predicting the response to these treatments would make it possible to envisage early therapeutic alternatives for patients identified as not very sensitive to standard treatments. IAPs (inhibitors of apoptosis proteins), which include XIAP, cIAP1 and cIAP2, are proteins involved in many cancers and capable of downregulating tumour cell apoptosis. It seems justified to investigate the role of these IAPs in resisting apoptosis-inducing anti-neoplastic treatments such as chemotherapy or radiotherapy. The aim of our study is to assess the prognostic role of overexpression of IAPs in locally advanced cervical cancer treated exclusively with radio-chemotherapy. This research seems all the more important as IAP-inhibiting molecules are currently being studied in other types of cancer (ear, nose and throat cancers) and appear to have a very encouraging radiosensitising effect. The hypothesis is that overexpression of IAPs in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy has a prognostic role on the local recurrence rate at 24 months.
Вмешательства
- Диагностический тест Immunohistochemistry
Blocks containing formalin-fixed, paraffin-embedded (FFPE) biopsies will be used to analyse the expression of XIAP, cIAP1 and cIAP2 proteins by immunohistochemistry. The antibodies will be selected on the basis of the literature and their validation for this technology (Schnoell et al. 2020). The immunohistochemical techniques will be performed on an automated immunolabelling machine (DakoLink®) after antigen demasking. The specific binding of primary antibodies will be revealed by the applicati
Первичные конечные точки
- Prognostic role of overexpression of XIAP on the rate of local recurrence in patients treated for locally advanced cervical cancer. [Срок оценки: Baseline]
- Prognostic role of overexpression of XIAP on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. [Срок оценки: 24 months]
- Prognostic role of overexpression of cIAP1 on the rate of local recurrence in patients treated for locally advanced cervical cancer. [Срок оценки: Baseline]
- Prognostic role of overexpression of cIAP1 on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. [Срок оценки: 24 months]
- Prognostic role of overexpression of cIAP2 on the rate of local recurrence in patients treated for locally advanced cervical cancer. [Срок оценки: Baseline]
- Prognostic role of overexpression of cIAP2 on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. [Срок оценки: 24 months]
- Local recurrence of cervical cancer [Срок оценки: Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.]
Вторичные конечные точки (12)
- A. Overall survival in patients treated for locally advanced cervical cancer at baseline. [Срок оценки: Baseline]
- A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer. [Срок оценки: 24 months]
- B. Progression-free survival in patients treated for locally advanced cervical cancer. [Срок оценки: Baseline]
- B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer. [Срок оценки: 24 months]
- B. Progression-free survival in patients treated for locally advanced cervical cancer: RECIST criteria [Срок оценки: Baseline]
- B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: RECIST criteria [Срок оценки: 24 months]
- B. Progression-free survival in patients treated for locally advanced cervical cancer. H-score [Срок оценки: Baseline]
- B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: H-score [Срок оценки: 24 months]
- C. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and Programmed Death - Ligand 1 expression. [Срок оценки: Baseline]
- C. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and Programmed Death - Ligand 1 expression. [Срок оценки: Baseline]
- C. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and Programmed Death - Ligand 1 expression. [Срок оценки: Baseline]
- D. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and lymphocytic tumour infiltration (LTI). [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Patients treated with the exclusive radio-chemotherapy combination for locally advanced cervical carcinoma (stage Ib-IVb according to FIGO classification).
- Patients aged ≥ 18 years.
- Patients with a minimum of 2 years post-treatment follow-up.
- Patients for whom the initial biopsy specimen (before treatment) is available.
- Patients who have not indicated that they do not wish to participate in the study.
- Patients affiliated to or benefiting from a health insurance scheme.
Критерии исключения
- Patients under court protection, guardianship or curatorship.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- CHU de Nîmes — Nîmes
Идентификаторы
NCT: NCT06147960 · NIMAO/2023-1/FF-01