The Biomarker Analysis in Locally Advanced Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

Official title:

The Biomarker Analysis in Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03635216
• Other study ID #: 18MMHIS060e
• Status: Active, not recruiting
• Start date: May 21, 2018
• Est. completion date: May 20, 2023

Study information

• Verified date: August 2018
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: May 20, 2023
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• cervical cancer patients

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

Exclusion Criteria:

• non-other cancer previously

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Hong JH, Tsai CS, Chang JT, Wang CC, Lai CH, Lee SP, Tseng CJ, Chang TC, Tang SG. The prognostic significance of pre- and posttreatment SCC levels in patients with squamous cell carcinoma of the cervix treated by radiotherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):823-30. — View Citation

Huang EY, Wang CJ, Chen HC, Fang FM, Huang YJ, Wang CY, Hsu HC. Multivariate analysis of para-aortic lymph node recurrence after definitive radiotherapy for stage IB-IVA squamous cell carcinoma of uterine cervix. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):834-42. doi: 10.1016/j.ijrobp.2008.01.035. Epub 2008 Apr 24. — View Citation

Ogino I, Nakayama H, Kitamura T, Okamoto N, Inoue T. The curative role of radiotherapy in patients with isolated para-aortic node recurrence from cervical cancer and value of squamous cell carcinoma antigen for early detection. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):630-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shh, Ptch-1, Smo and Gli1	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	1987-2002
Secondary	overall survival	The length of time from either the date of diagnosis or the start of treatment for cervical cancer	1987-2002
Secondary	progression free survival	the length of time during and after the treatment of cervical cancer	1987-2002
Secondary	local recurrence	cervical cancer that has recurred at or near the same place as the original tumor	1987-2002