NCT03635216

The Biomarker Analysis in Locally Advanced Cervical Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Cervical Neoplasms

Timeline

• Start date: 2018-05-21
• Primary completion: 2018-05-21
• Completion: 2023-05-20
• First posted: 2018-08-17
• Last updated: 2018-08-17

Locations

1 site across 1 country: Taiwan