The Biomarker Analysis in Locally Advanced Cervical Cancer
NCT ID: NCT03635216
Last Updated: 2018-08-17
Study Results
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Basic Information
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UNKNOWN
62 participants
OBSERVATIONAL
2018-05-21
2023-05-20
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* performance status Eastern Cooperative Oncology Group 0-1 (ECOG 0-1)
Exclusion Criteria
20 Years
80 Years
FEMALE
No
Sponsors
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Mackay Memorial Hospital
OTHER
Responsible Party
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Yu-Jen Chen
Chair
Principal Investigators
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Yu-Jen Chen, MD
Role: STUDY_CHAIR
Department of Radiation Oncology, MacKay Memorial Hospital
Locations
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Mackay Memorial Hospital
Taipei, , Taiwan
Countries
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References
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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. doi: 10.1016/s0360-3016(98)00147-3.
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. doi: 10.1111/j.1525-1438.2005.00119.x.
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.
Other Identifiers
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18MMHIS060e
Identifier Type: -
Identifier Source: org_study_id
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