Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer

August 28, 2020 updated by: David Cantu, National Institute of Cancerología

Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer: A Retrospective Study

Locally advanced cervical cáncer continues to be a public health problem in emergent economies, even though treatment is very well standardized, recurrence rate is still high, making necessary to evaluate prognostic clinical and pathological factors. The aim of this study is to evaluate clinical and pathological prognostic factor in terms of treatment outcomes, disease-free survival (DFS) and overall survival (OS) in a retrospective cohort of patients with LACC treated with standard chemoradiotherapy in a reference center in México.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective study, the data were obtained from clinical files of cervical cancer patients with clinical stages IB2-IVA(FIGO2009) treated at the Instituto Nacional de Cancerología in Mexico City from January 2005 to December 2014.

A total of 1954 patients with LACC confirmed by pathology, clinical exams and computed tomography scan (CT) were identified.

Demographic, clinical, pathological and follow-up as well as survival status of all patients was recorded. Treatment outcome was classified as complete response if the patient had no signs of tumor activity after 6 months of finishing treatment, persistence of disease was defined if tumor could be identified after treatment or before six months of treatment termination, progression was defined if tumor growth occurred or metastatic disease appeared. Disease-free survival (DFS) was defined as the period between finishing treatment and the occurrence of relapse, which was confirmed by pathological study and/or CT. Overall survival (OS) was defined as the time period between diagnosis and death or date at last visit. Quantitative variables were described with central tendency and dispersion measures and analyzed with Student's t or Mann-Whitney U test. Normality was determined with Shapiro-Wilk's test, Chi-squared for categorical comparisons between groups, Kaplan-Meir with the log-rank test for survival analysis were performed. The multivariate analysis was performed using Cox proportional Hazard regression model. Statistically significant differences were defined as a p value <0.05.

Statistical analyses were performed using IBM SPSS, version 23 (IBM Corp., Armonk, N.Y., USA).

Study Type

Observational

Enrollment (Actual)

1954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with Locally advanced cervical cancer confirmed by pathology, clinical exams and computed tomography scan (CT)

Description

Inclusion Criteria:

  • Patients with cervical cancer clinical stage Ib2-IVa
  • Treated with concomitant Chemoradiotherapy

Exclusion Criteria:

  • Rare histologies such gastric type adenocarcinoma, neuroendocrine or clear-cell carcinoma
  • incomplete treatment or not treated with chemoradiotherapy
  • Two primary malignancies
  • Insufficient data for analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Localy advanced Cervical Cancer
Patients with Localy advanced Cervical Cancer confirmed by pathology, clinical exams and computed tomography scan, treated with concurrent chemoradiotherapy.
Other: Descriptive and analytical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.
Time Frame: 5 years
Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of overall survival.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.
Time Frame: 6 months
Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of response rate of treatment.
6 months
Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.
Time Frame: 5 years
Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of disease-free survival.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cancerología

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2005

Primary Completion (ACTUAL)

December 31, 2014

Study Completion (ACTUAL)

July 30, 2020

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (ACTUAL)

September 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rev/050/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Direct request to the principal investigator

IPD Sharing Time Frame

Any time by direct request to the principal investigator

IPD Sharing Access Criteria

Only for research purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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