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

NCT ID: NCT04537273

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1954 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-02

Study Completion Date

2020-07-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Localy advanced Cervical Cancer

Patients with Localy advanced Cervical Cancer confirmed by pathology, clinical exams and computed tomography scan, treated with concurrent chemoradiotherapy.

Descriptive and analytical

Intervention Type OTHER

Interventions

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Descriptive and analytical

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cancerología

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Cantu

Md, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Gallardo-Alvarado L, Cantu-de Leon D, Ramirez-Morales R, Santiago-Concha G, Barquet-Munoz S, Salcedo-Hernandez R, Reyes C, Perez-Alvarez S, Perez-Montiel D, Perez-Plasencia C, Trejo-Duran E, Galicia JP. Tumor histology is an independent prognostic factor in locally advanced cervical carcinoma: A retrospective study. BMC Cancer. 2022 Apr 13;22(1):401. doi: 10.1186/s12885-022-09506-3.

Reference Type DERIVED
PMID: 35418030 (View on PubMed)

Other Identifiers

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Rev/050/18

Identifier Type: -

Identifier Source: org_study_id

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