Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03559803
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2018-04-09
Brief Title:
A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
A Prospective Study of Dynamic Monitoring Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Perspectives
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy
To evaluate the specific immune response throughout monitor the change of the programmed death-1PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To use immunohistochemistry IHC technique to monitor the change of programmed death-ligand 1 PD-L1CD68CD8CD4PD1 and Treg expression in biopsy at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To detect the change of T cell receptorTCR repertoire and Tumor mutation burden TMB at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy
To evaluate the specific immune response throughout monitor the change of the programmed death-1PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To use immunohistochemistry IHC technique to monitor the change of programmed death-ligand 1 PD-L1CD68CD8CD4PD1 and Treg expression in biopsy at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To detect the change of T cell receptorTCR repertoire and Tumor mutation burden TMB at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
Detailed Description:
Cervical cancer is the fourth most common cancer among women worldwide At present patients with cervical cancer are treated with radical hysterectomy and pelvic lymphadenectomy or chemoradiation To improve the prognosis of cervical cancer patients novel immunotherapeutic strategies need to be developed Now there are some clinical phase III trials ongoing to assess the effects of ipilimumab pembrolizumab and nivolumab in advanced cervical cancerbut information on the clinical significance of PD-L1 expression in cervical cancer is largely lackingIn this study the investigators primary objective
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy
To evaluate the specific immune response throughout monitor the change of PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To use IHC technique to monitor the change of PD-L1 CD68CD8CD4PD1 and Treg expression in biopsy at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To detect the change of TCR repertoire and TMB at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy
To evaluate the specific immune response throughout monitor the change of PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To use IHC technique to monitor the change of PD-L1 CD68CD8CD4PD1 and Treg expression in biopsy at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
To detect the change of TCR repertoire and TMB at baseline before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None