NCT02026648

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

January 1, 2014

Last Update Submit

September 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Outcome of women with cervical cancer

    20 years

Study Arms (1)

cases with cervical cancer

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the cases with cervical cancer

You may qualify if:

  • 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:
  • 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.
  • Pathologic information: deep stromal invasion, lymph-vascular space invasion, lymph node involvement, parametrium invasion, vaginal cut end and tumor size.
  • Survival data: disease-free and overall survival.
  • Radiation report, Chemotherapy treatment, operation, discharge and admission note.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

January 1, 2014

First Posted

January 3, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-02

Locations