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

NCT06147960 | Unknown

• 1 other identifier: NIMAO/2023-1/FF-01
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer of Cervix; Apoptosis

Keywords

Apoptosis inhibiting proteins; Cervical cancer; Apoptosis

Outcome Measures

Primary Outcomes (7)

• Prognostic role of overexpression of XIAP on the rate of local recurrence in patients treated for locally advanced cervical cancer.

  Overexpression of the Inhibitor of Apoptosis Proteins XIAP will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. The H-score for XIAP will be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

  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.

  Overexpression of the Inhibitor of Apoptosis Proteins XIAP will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. The H-score for XIAP will be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

  24 months

• Prognostic role of overexpression of cIAP1 on the rate of local recurrence in patients treated for locally advanced cervical cancer.

  Overexpression of Inhibitors of the Apoptosis Protein cIAP1 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.The H-score for cIAP1 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

  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.

  Overexpression of the Inhibitor of Apoptosis Protein cIAP1 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.The H-score for cIAP1 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

  24 months

• Prognostic role of overexpression of cIAP2 on the rate of local recurrence in patients treated for locally advanced cervical cancer.

  Overexpression of the Inhibitor of Apoptosis Protein cIAP2 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer.The H-score for cIAP2 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

  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.

  Overexpression of the Inhibitor of Apoptosis Protein cIAP2 will be measured to evaluate its prognostic role on the rate of local recurrence at 24 months follow-up in patients treated for locally advanced cervical cancer. The H-score for cIAP1 be recorded on a scale of 0 to 300 based on the intensity of carcinoma cells.

  24 months

• Local recurrence of cervical cancer

  Local recurrence of cervical cancer at 24 months follow-up according to RECIST v1.1 criteria: Yes/No. RECIST 1.1 is a standard way to measure the response of a tumor to treatment in which Complete Response = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. Partial Response = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.

Secondary Outcomes (14)

• A. Overall survival in patients treated for locally advanced cervical cancer at baseline.

  Baseline

• A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.

  24 months

• B. Progression-free survival in patients treated for locally advanced cervical cancer.

  Baseline

• B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer.

  24 months

• B. Progression-free survival in patients treated for locally advanced cervical cancer: RECIST criteria

  Baseline

Other Outcomes (14)

• Age

  Baseline

• Weight

  Baseline

• Height

  Baseline

Interventions

Immunohistochemistry DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All patients with a cervix
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients under court protection, guardianship or curatorship.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Institut du Cancer de Montpellier - Val d'Aurelle: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical biopsy specimens. Immunohistochemistry: blocks containing formalin-fixed, paraffin-embedded (FFPE) biopsies will be used to analyse the expression of XIAP, cIAP1 and cIAP2 proteins by immunohistochemistry. Evaluation of recurrence according to RECIST v1.1 criteria.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Alexandre TAYART de BORMS, Interne

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Cristina LEAHA, Dr.

  Institut Régional du Cancer de Montpellier, Service d'Anatomopathologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric FITENI, Dr.

CONTACT

+334.34.03.46.69; frederic.fiteni@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 28, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11