Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer
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- What is being studied
- The protocol lists: Immunohistochemistry.
- Who it may be relevant to
- Registry conditions: Cancer of Cervix, Apoptosis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on the 24-month Recurrence Rate in Locally Advanced Cervical Cancer
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- Prognostic role of overexpression of XIAP on the rate of local recurrence in patients treated for locally advanced cervical cancer. [Time frame: 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. [Time frame: 24 months]
- Prognostic role of overexpression of cIAP1 on the rate of local recurrence in patients treated for locally advanced cervical cancer. [Time frame: 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. [Time frame: 24 months]
- Prognostic role of overexpression of cIAP2 on the rate of local recurrence in patients treated for locally advanced cervical cancer. [Time frame: 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. [Time frame: 24 months]
- Local recurrence of cervical cancer [Time frame: Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.]
Secondary outcome measures (12)
- A. Overall survival in patients treated for locally advanced cervical cancer at baseline. [Time frame: Baseline]
- A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer. [Time frame: 24 months]
- B. Progression-free survival in patients treated for locally advanced cervical cancer. [Time frame: Baseline]
- B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer. [Time frame: 24 months]
- B. Progression-free survival in patients treated for locally advanced cervical cancer: RECIST criteria [Time frame: Baseline]
- B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: RECIST criteria [Time frame: 24 months]
- B. Progression-free survival in patients treated for locally advanced cervical cancer. H-score [Time frame: Baseline]
- B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: H-score [Time frame: 24 months]
- C. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and Programmed Death - Ligand 1 expression. [Time frame: Baseline]
- C. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and Programmed Death - Ligand 1 expression. [Time frame: Baseline]
- C. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and Programmed Death - Ligand 1 expression. [Time frame: Baseline]
- D. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and lymphocytic tumour infiltration (LTI). [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patients under court protection, guardianship or curatorship.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU de Nîmes — Nîmes
Identifiers
NCT: NCT06147960 · NIMAO/2023-1/FF-01