Locally Advanced Cervical CancerNCT06068387
A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis
A study testing surgical staging in people with Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 28 Feb 2026
- Phase
- Interventional
- 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
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.
- Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment.
- ECOG score:0 ~ 1.
- The expected survival time>6 months;
- There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance.
Who cannot join
- History of immune disease who need to take immunosuppressive drugs.
- History of serious mental illness and brain functional disorder.
- Other malignancies were diagnosed within five years or needed treatments.
- Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
- Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
- Patients who cannot understand the research regimen and refuse to sign the informed consent form.
- Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing
Jun Qi, M.D., 13036399093, kjb65310859@163.com
About this study
Official title: A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis
The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are:
- Is the para-aortic lymph node metastasis prediction model accurate and feasible?
- Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.
- 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 | Experimental | 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.
The accuracy of the prediction model
The performance of the model was assessed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the calibration curve, Hosmer-Lemeshow test and Brier score. The investigators will calculate respectively the sensitivity and 95% confidence interval (CI), specificity and 95% CI, positive likelihood ratios (LR+) and 95% CI, negative likelihood ratios (LR-) and 95% CI, and the Kappa value.
Measured: 2 years
Secondary outcomes (3)
PFS
Progression-free Survival
Measured: 3 years
LRR
The local recurrence rate of para-aortic lymphatic drainage area
Measured: 1 year
LRR
The local recurrence rate of para-aortic lymphatic drainage area
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
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
- NCT06068387
- Sponsor's protocol ID
- CQGOG0109
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2023
- Last updated
- 10 Oct 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis
- ClinicalTrials.gov ID
- NCT06068387
- Acronym / sponsor ID
- CQGOG0109
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 5 Oct 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 prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are:
- Is the para-aortic lymph node metastasis prediction model accurate and feasible?
- Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | 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
Key inclusion criteria (7 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.
- Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment.
- ECOG score:0 ~ 1.
Key exclusion criteria (7 listed)
- History of immune disease who need to take immunosuppressive drugs.
- History of serious mental illness and brain functional disorder.
- Other malignancies were diagnosed within five years or needed treatments.
- Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
- Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
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
The accuracy of the prediction model
Time frame: 2 years
The performance of the model was assessed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the calibration curve, Hosmer-Lemeshow test and Brier score. The investigators will calculate respectively the sensitivity and 95% confidence interval (CI), specificity and 95% CI, positive likelihood ratios (LR+) and 95% CI, negative likelihood ratios (LR-) and 95% CI, and the Kappa value.
3 secondary outcomes
PFS
Time frame: 3 years
LRR
Time frame: 1 year
LRR
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Related trials for Locally Advanced Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Locally Advanced Head and Neck Carcinoma
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?
A study testing surgical staging in people with 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongling Zou, M.D. (13657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the prediction model (time frame: 2 years). 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 10 Oct 2023.