Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03635216
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2018-08-15
Brief Title:
The Biomarker Analysis in Locally Advanced Cervical Cancer
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
The Biomarker Analysis in Locally Advanced Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2018-08
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:
Sonic hedgehog Shh signaling including Gli1 is critical to treatment resistance For optimizing cervical cancer treatment the pathological prognostic factors determine whether to administer adjuvant therapy However the majority of clinical results was from squamous cell carcinoma rendering conclusions for adenocarcinoma less convincing We aimed to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery
Detailed Description:
Surgery radiotherapy and chemotherapy could achieve favorable locoregional control in cervical cancer Although good local control results distant failure plays a major role in patients with treatment failure
We were interested in the potential biomarkers for recurrence after primary treatment for the following reasons We wanted to identify patients at a high risk of recurrence Such patients must be intensively monitored We required baseline data such as the actuarial relapse rate for evaluation in an additional randomized study Hence we retrospectively analyzed the potential biomarkers for recurrence in cervical cancer Statistical analysis of the data was done using the chi-square test Disease free survival curves were constructed using the Kaplan-Meier method Comparisons between curves were performed using the log-rank test Multivariate analyses of factors associated with local and distant failure were made by logistic regression analysis
From 1987 to 2002 62 patients with cervical adenocarcinoma that received major surgery were enrolled for analysis of Shh signaling with a median follow-up period for 1726 months IQR 330-2262 months External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mgm2 Clinical outcomes in terms of local recurrence progression free survival PFS and overall survival OS will be analyzed The expressions of Shh Ptch-1 Smo and Gli1 were assessed by immunohistochemistry Statistics will be performed using International Business Machines IBM Statistical Package for the Social Science SPSS v22
We were interested in the potential biomarkers for recurrence after primary treatment for the following reasons We wanted to identify patients at a high risk of recurrence Such patients must be intensively monitored We required baseline data such as the actuarial relapse rate for evaluation in an additional randomized study Hence we retrospectively analyzed the potential biomarkers for recurrence in cervical cancer Statistical analysis of the data was done using the chi-square test Disease free survival curves were constructed using the Kaplan-Meier method Comparisons between curves were performed using the log-rank test Multivariate analyses of factors associated with local and distant failure were made by logistic regression analysis
From 1987 to 2002 62 patients with cervical adenocarcinoma that received major surgery were enrolled for analysis of Shh signaling with a median follow-up period for 1726 months IQR 330-2262 months External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mgm2 Clinical outcomes in terms of local recurrence progression free survival PFS and overall survival OS will be analyzed The expressions of Shh Ptch-1 Smo and Gli1 were assessed by immunohistochemistry Statistics will be performed using International Business Machines IBM Statistical Package for the Social Science SPSS v22
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?:
None
Is an FDA AA801 Violation?:
None