Clinical trial NCT06147960: Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer
Official title: Evaluation of the Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on the 24-month Recurrence Rate in Locally Advanced Cervical Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer of Cervix
Apoptosis
Keywords: Apoptosis inhibiting proteins
Cervical cancer
Apoptosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Institut du Cancer de Montpellier - Val d'Aurelle
First posted: 2023-11-28
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Primary outcomes:
measure: Prognostic role of overexpression of XIAP on the rate of local recurrence in patients treated for locally advanced cervical cancer.
timeFrame: Baseline
measure: 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.
timeFrame: 24 months
measure: Prognostic role of overexpression of cIAP1 on the rate of local recurrence in patients treated for locally advanced cervical cancer.
timeFrame: Baseline
measure: 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.
timeFrame: 24 months
measure: Prognostic role of overexpression of cIAP2 on the rate of local recurrence in patients treated for locally advanced cervical cancer.
timeFrame: Baseline
measure: 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.
timeFrame: 24 months
measure: Local recurrence of cervical cancer
timeFrame: Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.
Secondary outcomes:
measure: A. Overall survival in patients treated for locally advanced cervical cancer at baseline.
timeFrame: Baseline
measure: A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.
timeFrame: 24 months
measure: B. Progression-free survival in patients treated for locally advanced cervical cancer.
timeFrame: Baseline
measure: B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer.
timeFrame: 24 months
measure: B. Progression-free survival in patients treated for locally advanced cervical cancer: RECIST criteria
timeFrame: Baseline
measure: B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: RECIST criteria
timeFrame: 24 months
measure: B. Progression-free survival in patients treated for locally advanced cervical cancer. H-score
timeFrame: Baseline
measure: B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: H-score
timeFrame: 24 months
measure: C. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and Programmed Death - Ligand 1 expression.
timeFrame: Baseline
measure: C. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and Programmed Death - Ligand 1 expression.
timeFrame: Baseline
measure: C. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and Programmed Death - Ligand 1 expression.
timeFrame: Baseline
measure: D. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and lymphocytic tumour infiltration (LTI).
timeFrame: Baseline
measure: D. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and lymphocytic tumour infiltration (LTI).
timeFrame: Baseline
measure: D. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and lymphocytic tumour infiltration (LTI).
timeFrame: Baseline
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Radiotherapy protocol
timeFrame: Baseline
measure: Chemotherapy
timeFrame: Baseline
measure: Brachytherapy
timeFrame: Baseline
measure: Anatomopathology of cervical cancer: histology
timeFrame: Baseline
measure: Anatomopathology of cervical cancer: FIGO stage
timeFrame: Baseline
measure: Family and personal history
timeFrame: Baseline
measure: Co-medications
timeFrame: Baseline
measure: Initial clinical features
timeFrame: Baseline
measure: Lifestyle
timeFrame: Baseline
measure: Follow-up
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Treatments received after progression
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Locations:
Study officials:
affiliation: Nîmes University Hospital
name: Alexandre TAYART de BORMS, Interne
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Régional du Cancer de Montpellier, Service d'Anatomopathologie
name: Cristina LEAHA, Dr.
role: PRINCIPAL_INVESTIGATOR
References: