Locally Advanced Cervical CancerNCT05717751
Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer
An observational study of Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
The goal of this observational study is to identify predictive factors and to develop a risk model predicting para-aortic lymph node metastasis in patients with locally advanced cervical cancer based on the analysis of surgical staging results. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- surgical staging
- Type of treatment
- Surgery or procedure
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to 12 Dec 2022
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The primary cohort of this study comprised an evaluation of the institutional database for medical records from January 2020 to August 2022 to identify patients with locally advanced cervical cancer who underwent surgical staging. From March 2018 to December 2019, an independent validation cohort of 116 consecutive patients was screened using the same criteria as that for the primary cohort.
Who may be able to join
- In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
- It was treated initially without surgical and chemotherapy.
- Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
- Abdominal pelvic CT, MRI or PET/CT were performed before treatment.
- Patients with successful surgical staging and the pathological data of para-aortic lymph node were obtained.
Who cannot join
- Patients were excluded if the histopathological type was not squamous cell carcinoma or Adenocarcinoma, and the data of LN status was not available.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
About this study
Official title: Predictors of Para-aortic Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer Based on the Pooled Analysis of Surgical Staging Results
The goal of this observational study is to identify predictive factors and to develop a risk model predicting para-aortic lymph node metastasis in patients with locally advanced cervical cancer based on the analysis of surgical staging results. The main questions it aims to answer are:
- What are the risk factors to predict para-aortic lymph node metastasis in patients with locally advanced cervical cancer?
- What is the indication for prophylactic extended-field radiation therapy in patients with locally advanced cervical cancer Individual data of patients with locally advanced cervical cancer treated with surgical staging at our institution from 2020 to 2022 were pooled analysed.Multivariate Logistic regression analysis was used to identify the predictive factors and to develop the prediction model.
Read the detailed description
Individual data of 336 patients with locally advanced cervical cancer treated with surgical staging at our institution from January 2020 to August 2022 were pooled analysed. The following factors were collected from each patient to identify variables predicting para-aortic lymph node metastasis: age, T-staging，histopathological type，tumor size, differentiation, pretreatment tumor markers (squamous carcinoma antigen, carcinoembryonic antigen, Carbohydrate antigen 125 and cytokeratin fragment 21-1 , human papilloma virus type, the status of pelvic lymph node on images, common iliac lymph node and the short-axis diameter of the largest positive and the status of para-aortic lymph node on surgical staging results. Multivariate Logistic regression analysis was used to develop the prediction model. A simplified scoring system for each independent predictive factors was developed according to its coefficient. Internal validation was performed to assess the model. An independent validation cohort contained 116 patients with the same criteria from March 2018 to December 2019.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- surgical staging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical stagingProcedure or surgery
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | locally advanced cervical cancer treated with surgical staging Receives: Procedure: surgical staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of para-aortic lymph node metastasis
We evaluate the institutional database for medical records to identify patients who underwent surgical staging, then comprised the primary and the independent validation cohort, respectively. The variables were collected from each patient. We assess the bivariate relationship between each variable and para-aortic lymph node metastasis via logistic regression analysis. The potential predictive variables of a P-value<0.05 on univariate analysis were considered as risk factors.
Measured: 3 months
The prediction model of para-aortic lymph node metastasis
The multivariable logistic regression analysis between predictors and para-aortic lymph node metastasis was conducted and evaluated odds ratio. To facilitate practical application, a score chart was developed to present the final prediction model. The risk score of predictive variables were calculated and rounded based on its beta-coefficients from the multivariate logistic regression analysis. The prediction model was then developed by combining all scores, and the sum of scores for each predictor represented the risk score for every patient.
Measured: 3 months
Secondary outcomes (1)
validation of the prediction model
We adopted an internal and independent validation to assess the performance of the prediction model.The internal validation of the model was performed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the Hosmer-Lemeshow test and Brier score. The independent validation was performed with respect to sensitivity, specificity and Youden index, which calculated by sensitivity+specificity-1 is a global measure of diagnostic effectiveness.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start13 Apr 2022
- Primary completion12 Nov 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongling Zou, Chongqing University Cancer Hospital
- Investigators
- Dongling Zou, M.D., Study director, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717751
- Sponsor's protocol ID
- CQGOG0110
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Para-aortic Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer Based on the Pooled Analysis of Surgical Staging Results
- ClinicalTrials.gov ID
- NCT05717751
- Acronym / sponsor ID
- CQGOG0110
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 8 Feb 2023 (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.
The goal of this observational study is to identify predictive factors and to develop a risk model predicting para-aortic lymph node metastasis in patients with locally advanced cervical cancer based on the analysis of surgical staging results. The main questions it aims to answer are:
- What are the risk factors to predict para-aortic lymph node metastasis in patients with locally advanced cervical cancer?
- What is the indication for prophylactic extended-field radiation therapy in patients with locally advanced cervical cancer Individual data of patients with locally advanced cervical cancer treated with surgical staging at our institution from 2020 to 2022 were pooled analysed.Multivariate Logistic regression analysis was used to identify the predictive factors and to develop the prediction model.
Detailed description
Individual data of 336 patients with locally advanced cervical cancer treated with surgical staging at our institution from January 2020 to August 2022 were pooled analysed. The following factors were collected from each patient to identify variables predicting para-aortic lymph node metastasis: age, T-staging，histopathological type，tumor size, differentiation, pretreatment tumor markers (squamous carcinoma antigen, carcinoembryonic antigen, Carbohydrate antigen 125 and cytokeratin fragment 21-1 , human papilloma virus type, the status of pelvic lymph node on images, common iliac lymph node and the short-axis diameter of the largest positive and the status of para-aortic lymph node on surgical staging results. Multivariate Logistic regression analysis was used to develop the prediction model. A simplified scoring system for each independent predictive factors was developed according to its coefficient. Internal validation was performed to assess the model. An independent validation cohort contained 116 patients with the same criteria from March 2018 to December 2019.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Procedure: surgical staginglocally advanced cervical cancer treated with surgical staging |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary cohort of this study comprised an evaluation of the institutional database for medical records from January 2020 to August 2022 to identify patients with locally advanced cervical cancer who underwent surgical staging. From March 2018 to December 2019, an independent validation cohort of 116 consecutive patients was screened using the same criteria as that for the primary cohort.
Key inclusion criteria (5 listed)
- In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
- It was treated initially without surgical and chemotherapy.
- Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
- Abdominal pelvic CT, MRI or PET/CT were performed before treatment.
- Patients with successful surgical staging and the pathological data of para-aortic lymph node were obtained.
Key exclusion criteria (1 listed)
- Patients were excluded if the histopathological type was not squamous cell carcinoma or Adenocarcinoma, and the data of LN status was not available.
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 |
|---|---|---|
| surgical stagingpara-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy | Procedure or surgery | experimental group |
Primary outcome
Predictors of para-aortic lymph node metastasis
Time frame: 3 months
We evaluate the institutional database for medical records to identify patients who underwent surgical staging, then comprised the primary and the independent validation cohort, respectively. The variables were collected from each patient. We assess the bivariate relationship between each variable and para-aortic lymph node metastasis via logistic regression analysis. The potential predictive variables of a P-value<0.05 on univariate analysis were considered as risk factors.
The prediction model of para-aortic lymph node metastasis
Time frame: 3 months
The multivariable logistic regression analysis between predictors and para-aortic lymph node metastasis was conducted and evaluated odds ratio. To facilitate practical application, a score chart was developed to present the final prediction model. The risk score of predictive variables were calculated and rounded based on its beta-coefficients from the multivariate logistic regression analysis. The prediction model was then developed by combining all scores, and the sum of scores for each predictor represented the risk score for every patient.
1 secondary outcome
validation of the prediction model
Time frame: 3 months
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 8 Feb 2023.
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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.
Dongling Zou, M.D. study director
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
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 5 inclusion and 1 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Predictors of para-aortic lymph node metastasis (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.