NCT04537273

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,954

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2005

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

10 years

First QC Date

August 25, 2020

Last Update Submit

August 28, 2020

Conditions

Cervical Cancer

Keywords

Locally advancedCervical carcinomaPrognostic factors

Outcome Measures

Primary Outcomes (1)

  • Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.

    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 Outcomes (2)

  • Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.

    6 months

  • Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer.

    5 years

Study Arms (1)

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

Interventions

Descriptive and analyticalOTHER
Localy advanced Cervical Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35418030DERIVED

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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, PhD

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 3, 2020

Study Start

January 2, 2005

Primary Completion

December 31, 2014

Study Completion

July 30, 2020

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Direct request to the principal investigator

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Any time by direct request to the principal investigator
Access Criteria
Only for research purpose.