Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients under court protection, guardianship or curatorship.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Immunohistochemistry
Diagnostic testBlocks 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
24 months3
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.
Time frame
Baseline4
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.
Time frame
24 monthsSecondary outcomes
1
A. Overall survival in patients treated for locally advanced cervical cancer at baseline.
Death will be recorded as YES/NO
Time frame
Baseline2
A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer.
Death will be recorded as YES/NO
Time frame
24 months3
B. Progression-free survival in patients treated for locally advanced cervical cancer.
The time from diagnosis to death from any cause will be recorded in months and days.
Time frame
Baseline4
B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer.
The time from diagnosis to death from any cause will be recorded in months and days.
Time frame
24 monthsOther outcomes
1
Age
Age will be recorded in years
Time frame
Baseline2
Weight
Weight will be recorded in kilograms
Time frame
Baseline3
Height
Height will be recorded in centimeters
Time frame
Baseline4
Radiotherapy protocol
The patient's radiotherapy protocol will be recorded
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Nīmes
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborator
Source ClinicalTrials.gov