Cervical CancerNCT04537273
Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer
An observational study of Cervical Cancer, run by National Institute of Cancerología.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Descriptive and analytical
- How many people
- 1,954 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2005to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Locally advanced cervical cancer confirmed by pathology, clinical exams and computed tomography scan (CT)
Who may be able to join
- Patients with cervical cancer clinical stage Ib2-IVa
- Treated with concomitant Chemoradiotherapy
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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).
- Conditions
- Cervical Cancer
- Being tested
- Descriptive and analytical
- Keywords
- Locally advanced, Cervical carcinoma, Prognostic factors
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive and analyticalOther
| Study group | Role | What they receive |
|---|---|---|
| Localy advanced Cervical Cancer | Patients with Localy advanced Cervical Cancer confirmed by pathology, clinical exams and computed tomography scan, treated with concurrent chemoradiotherapy. Receives: Other: Descriptive and analytical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
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 response rate of treatment.
Measured: 6 months
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 disease-free survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start2 Jan 2005
- Primary completion31 Dec 2014
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,954 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Cantu, National Institute of Cancerología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537273
- Sponsor's protocol ID
- Rev/050/18
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Direct request to the principal investigator
Publications
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.
PubMed 35418030
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04537273
- Acronym / sponsor ID
- Rev/050/18
- Conditions
- Cervical Cancer
- Keywords
- Locally advanced, Cervical carcinoma, Prognostic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,954 participants (actual)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- 2 Jan 2005 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localy advanced Cervical Cancer | – | Other: Descriptive and analyticalPatients with Localy advanced Cervical Cancer confirmed by pathology, clinical exams and computed tomography scan, treated with concurrent chemoradiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Locally advanced cervical cancer confirmed by pathology, clinical exams and computed tomography scan (CT)
Key inclusion criteria (2 listed)
- Patients with cervical cancer clinical stage Ib2-IVa
- Treated with concomitant Chemoradiotherapy
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descriptive and analytical | Other | Localy advanced Cervical Cancer |
Primary outcome
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.
2 secondary outcomes
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 as prognostic factor of patients with locally advanced cervical cancer.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 35418030Gallardo-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.
- Individual participant dataSharing planned: Yes. Direct request to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by National Institute of Cancerología.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.