The Biomarker Analysis in Locally Advanced Cervical Cancer

• Conditions: Uterine Cervical Neoplasms

• Registration Number: NCT03635216
• Lead Sponsor: Mackay Memorial Hospital

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 172.6 months (IQR 33.0-226.2 months). External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mg/m2. 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 Timeline

• Study Start: 2018-05-21
• Primary Completion: 2018-05-21
• Status Verified: 2018-08
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17
• Study Completion: 2023-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• cervical cancer patients
• performance status Eastern Cooperative Oncology Group 0-1 (ECOG 0-1)

Exclusion Criteria

• non-other cancer previously

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shh, Ptch-1, Smo and Gli1	1987-2002	Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery

Secondary Outcome Measures

Name	Time	Method
local recurrence	1987-2002	cervical cancer that has recurred at or near the same place as the original tumor
overall survival	1987-2002	The length of time from either the date of diagnosis or the start of treatment for cervical cancer
progression free survival	1987-2002	the length of time during and after the treatment of cervical cancer

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan