Cancer of Cervix Clinical Trial
— EPIcolOfficial title:
Evaluation of the Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on the 24-month Recurrence Rate in Locally Advanced Cervical Cancer
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.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | November 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centre Hospitalier Universitaire de Nimes | Institut du Cancer de Montpellier - Val d'Aurelle |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | Age will be recorded in years | Baseline | |
Other | Weight | Weight will be recorded in kilograms | Baseline | |
Other | Height | Height will be recorded in centimeters | Baseline | |
Other | Radiotherapy protocol | The patient's radiotherapy protocol will be recorded | Baseline | |
Other | Chemotherapy | Details of the patient's chemotherapy will be recorded (drugs and dosage) | Baseline | |
Other | Brachytherapy | Details of the patient's brachytherapy will be recorded (type of internal radiation and dosage) | Baseline | |
Other | Anatomopathology of cervical cancer: histology | The histology of the patient's cervical cancer will be recorded | Baseline | |
Other | Anatomopathology of cervical cancer: FIGO stage | The FIGO stage of the patient's cervical cancer will be recorded. FIGO staging ranges from Stage I= Confined to the uterine corpus and ovary to Stage IIB=Substantial lymphovascular space involvement of non-aggressive histological types. | Baseline | |
Other | Family and personal history | The patient's family and personal history will be recorded | Baseline | |
Other | Co-medications | Any other concommitant treatment will be recorded | Baseline | |
Other | Initial clinical features | The initial clinical features of the disease will be recorded | Baseline | |
Other | Lifestyle | The patient's lifestyle (marital status, children, hobbies, professional status) will be recorded | Baseline | |
Other | Follow-up | All details of follow-up of the patient's oncological pathology (response rate, date of progression, date of death) will be recorded. | 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 | |
Other | Treatments received after progression | Details of all treatments received after disease progression will be recorded | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | A. Overall survival in patients treated for locally advanced cervical cancer at baseline. | Death will be recorded as YES/NO | Baseline | |
Secondary | A. Overall survival at 24 months follow-up in patients treated for locally advanced cervical cancer. | Death will be recorded as YES/NO | 24 months | |
Secondary | 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. | Baseline | |
Secondary | 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. | 24 months | |
Secondary | B. Progression-free survival in patients treated for locally advanced cervical cancer: RECIST criteria | The time between diagnosis and progression according to v1.1 of the RECIST criteria or death from any cause will be recorded in days.
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. |
Baseline | |
Secondary | B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: RECIST criteria | The time between diagnosis and progression according to v1.1 of the RECIST criteria or death from any cause will be recorded in days.
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. |
24 months | |
Secondary | B. Progression-free survival in patients treated for locally advanced cervical cancer. H-score | The histochemical scoring assessment (H-SCORE) will be recorded on a scale of 0-300 | Baseline | |
Secondary | B. Progression-free survival at 24 months follow-up in patients treated for locally advanced cervical cancer: H-score | The histochemical scoring assessment (H-SCORE) will be recorded on a scale of 0-300 | 24 months | |
Secondary | C. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and Programmed Death - Ligand 1 expression. | The expression level of XIAP and the expression level of PD-L1 in biopsies will be measured by immunohistochemistry. | Baseline | |
Secondary | C. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and Programmed Death - Ligand 1 expression. | The expression level of cIAP1 and the expression level of PD-L1 in biopsies will be measured by immunohistochemistry. | Baseline | |
Secondary | C. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and Programmed Death - Ligand 1 expression. | The expression levels of cIAP2 and expression level of PD-L1 in biopsies will be measured by immunohistochemistry. | Baseline | |
Secondary | D. Correlation between the Inhibitor of Apoptosis Protein XIAP expression and lymphocytic tumour infiltration (LTI). | The expression level of XIAP and the level of lymphocytic tumour infiltration will be measured as % in biopsies. | Baseline | |
Secondary | D. Correlation between the Inhibitor of Apoptosis Protein cIAP1 expression and lymphocytic tumour infiltration (LTI). | The expression level of cIAP1 and the level of lymphocytic tumour infiltration will be measured as % in biopsies. | Baseline | |
Secondary | D. Correlation between the Inhibitor of Apoptosis Protein cIAP2 expression and lymphocytic tumour infiltration (LTI). | The expression level of cIAP2 and the level of lymphocytic tumour infiltration will be measured as % in biopsies. | Baseline |
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