Outcome of Women With Cervical Cancer

Cervical Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026648
• Other study ID #: 102159-E
• Status: Completed
• Phase: N/A
• First received: January 1, 2014
• Last updated: September 5, 2016
• Start date: January 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix over the same period.

Our understanding of the natural history and optimal management of AC is limited. It appears that AC and SCC of the cervix behave differently. They are different in epidemiology, prognostic factors, and patterns of failure after similar treatments. Available data suggest that they may also differ in their response to treatment. We postulate that new treatment strategies specifically tailored to AC should be explored.

However, there is few data about outcome of cervical cancer in Taiwan. So we propose this proposal for retrospective analysis of clinicopathological parameters and outcomes in patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Time interval: from 1991 to date.

• Comprehensive surgical staging, debulking procedure, radiotherapy or chemotherapy.

• All female patients with cervical cancer who underwent treatment for cervical cancer at Far Eastern Memorial Hospital.

• All the patients diagnosed as cervical cancer, especially for women with adeno- and adenosquamous carcinoma.

• To review:

1. Clinical data: including age at diagnosis, presenting symptoms, gravidity, parity, menstrual history, body mass index, history of diabetes, hypertension, personal history of cancer and staging.

2. Pathologic information: deep stromal invasion, lymph-vascular space invasion, lymph node involvement, parametrium invasion, vaginal cut end and tumor size.

3. Survival data: disease-free and overall survival.

4. Radiation report, Chemotherapy treatment, operation, discharge and admission note.

Exclusion Criteria:

• Not comprehensive staging/debulking procedure.

• Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.

• Female minors or disabled persons.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Banqiao	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome of women with cervical cancer		20 years	No