The Biomarker Analysis in Locally Advanced Cervical Cancer

• ClinicalTrials.gov Identifier: NCT03635216
• Recruitment Status: Active, not recruiting
• First Posted: August 17, 2018
• Last Update Posted: August 17, 2018
• Sponsor: Mackay Memorial Hospital
• Information provided by (Responsible Party): Yu-Jen Chen, Mackay Memorial Hospital

Study Description

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.

Condition or disease
Uterine Cervical Neoplasms

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 Design

• Study Type: Observational
• Estimated Enrollment: 62 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Biomarker Analysis in Locally Advanced Cervical Cancer
• Actual Study Start Date: May 21, 2018
• Actual Primary Completion Date: May 21, 2018
• Estimated Study Completion Date: May 20, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Shh, Ptch-1, Smo and Gli1 [ Time Frame: 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 :

1. overall survival [ Time Frame: 1987-2002 ]
   The length of time from either the date of diagnosis or the start of treatment for cervical cancer
2. progression free survival [ Time Frame: 1987-2002 ]
   the length of time during and after the treatment of cervical cancer
3. local recurrence [ Time Frame: 1987-2002 ]
   cervical cancer that has recurred at or near the same place as the original tumor

Biospecimen Retention:   Samples Without DNA

cervical cancer specimen for immunohistochemistry staining

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: cervical cancer only occurring in women
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with cervical adenocarcinoma that received major surgery. External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mg/m2.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• non-other cancer previously

Contacts and Locations

Locations

Taiwan

Mackay Memorial Hospital

Taipei, Taiwan, 104

Sponsors and Collaborators

Mackay Memorial Hospital

Investigators

• Study Chair: Yu-Jen Chen, MD; Department of Radiation Oncology, MacKay Memorial Hospital

More Information

Publications:

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.

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.

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.

• Responsible Party: Yu-Jen Chen, Chair, Mackay Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03635216
• Other Study ID Numbers: 18MMHIS060e
• First Posted: August 17, 2018
• Last Update Posted: August 17, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yu-Jen Chen, Mackay Memorial Hospital:

Cervical cancer; Biomarker; Recurrence

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases