Clinical trial NCT04537273: Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer
Official title: Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Locally advanced
Cervical carcinoma
Prognostic factors
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2020-09-03
Enrollment: 1954
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Locally advanced cervical cancer confirmed by pathology, clinical exams and computed tomography scan (CT)

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.
timeFrame: 5 years
Secondary outcomes:
measure: Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.
timeFrame: 6 months
measure: Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.