Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer

Trial Title: Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer

NCT ID: NCT06147960

Condition: Cancer of Cervix
Apoptosis

Conditions: Official terms:
Uterine Cervical Neoplasms
Recurrence

Conditions: Keywords:
Apoptosis inhibiting proteins
Cervical cancer
Apoptosis

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Immunohistochemistry
Description: 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 application of Flex reagent (Dako Agilent), a dextran polymer coupled on the one hand to anti-mouse and anti-rabbit immunoglobulins, and on the other hand to a large number of horseradish peroxidase (HRP) molecules. 3,3'-Diaminobenzidine (DAB) will be used as a substrate for this enzyme to highlight the specific expression of the biomarker. The use of an automated system will ensure the reproducibility of inter-sample labelling.

Summary: 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.

Criteria for eligibility:

Study pop:
The study population is made up of women treated with the exclusive radio-chemotherapy combination for locally advanced cervical carcinoma, managed at the Montpellier Institute of Cancer and Montpellier and Nîmes University Hospitals.

Sampling method: Probability Sample
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.

Gender: Female

Gender based: Yes

Gender description: All patients with a cervix

Minimum age: 18 Years

Maximum age: N/A

Start date: November 2023

Completion date: November 2024

Lead sponsor:
Agency: Centre Hospitalier Universitaire de Nīmes
Agency class: Other

Collaborator:
Agency: Institut du Cancer de Montpellier - Val d'Aurelle
Agency class: Other

Source: Centre Hospitalier Universitaire de Nīmes

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06147960