Cervical CancerNCT06032481
System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer
An observational study of Cervical Cancer, run by Fujian Maternity and Child Health Hospital.
Trial summary
The lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 426 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 15 Mar 2023
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 426 patients with cervical cancer who underwent radical resection in China were recruited
Who may be able to join
- Clinical diagnosis of cervical cancer
- FIGO stage IB1-IIA1
- Undergone radical hysterectomy with pelvic lymphadenectomy
- Peformed pelvic MRI examination preoperatively
Who cannot join
- Had distant metastases diagnosed before or during the surgery
- Underwent neoadjuvant radiotherapy preoperatively
- Underwent neoadjuvant chemotherapy preoperatively
- Incomplete or inaccuratemedical records
About this study
Official title: Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer
The lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation.
Read the detailed description
Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or computed tomography (CT) tests are less sensitive to assess the risk of lymph node metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.
- Conditions
- Cervical Cancer
- Being tested
- surgery
- 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.
surgeryProcedure or surgery
Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
death or loss of follow-up
Measured: 60 months
Secondary outcomes (2)
Risk factors influenced LNM
A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.
Measured: 60 months
The accuracy of the model
The AUC curve was used to assess the discrimination of the scoring system. The comparison between predicted (mean ± SD) and observed rates of LNM was used to test the calibration. The Hosmer-Lemeshow test evaluated the model fit.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2012
- Primary completion1 Dec 2019
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yebin Feng, Fujian Maternity and Child Health Hospital
- Investigators
- Pengming Sun, Ph.D, Principal investigator, Fujian Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032481
- Sponsor's protocol ID
- FujianMCHH-Xu01
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer
- ClinicalTrials.gov ID
- NCT06032481
- Acronym / sponsor ID
- FujianMCHH-Xu01
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 13 Sep 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 lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation.
Detailed description
Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or computed tomography (CT) tests are less sensitive to assess the risk of lymph node metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 426 patients with cervical cancer who underwent radical resection in China were recruited
Key inclusion criteria (4 listed)
- Clinical diagnosis of cervical cancer
- FIGO stage IB1-IIA1
- Undergone radical hysterectomy with pelvic lymphadenectomy
- Peformed pelvic MRI examination preoperatively
Key exclusion criteria (4 listed)
- Had distant metastases diagnosed before or during the surgery
- Underwent neoadjuvant radiotherapy preoperatively
- Underwent neoadjuvant chemotherapy preoperatively
- Incomplete or inaccuratemedical records
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 |
|---|---|---|
| surgeryPatients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy | Procedure or surgery | – |
Primary outcome
Overall survival
Time frame: 60 months
death or loss of follow-up
2 secondary outcomes
Risk factors influenced LNM
Time frame: 60 months
The accuracy of the model
Time frame: 60 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 13 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Pengming Sun, Ph.D principal investigator
Fujian Maternity and Child Health Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Fujian Maternity and Child Health Hospital.
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 4 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 13 Sep 2023. 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?
Overall survival (time frame: 60 months). 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 13 Sep 2023.