Cervical CancerNCT05904977
Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer
An observational study of Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2024
- How long will I take part?
- 5 Years
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter).
Who may be able to join
- Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma)
- Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis
- Stage IA2-IIA2 ( FIGO 2018)
- Treated initially or just underwent cervical conization before
- Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team
- Underwent the bilateral type C AL-VUL resection during the surgery
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Not stage IA2-IIA2 ( FIGO 2018)
- History of abdominal or pelvic radiotherapy
- Evidence of metastatic disease detected by PECT, MRI or CT
- The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery
- Patients with other mailgnant tumors except cervical cancer
- Incompetence of the clinical, surgical and pathological data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huaiwu Lu
Guangzhou, Guangdong, 520120
Huaiwu Lu, 18688395806, luhuaiwu@mail.sysu.edu.cn
About this study
The purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary complications.
Read the detailed description
The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). The anterior leaf of the VUL in the type C resection group was sent to pathological biopsy separately, and the metastasis rate was further clarified by the pathological "ultrastaging" method. By comparing the clinicopathological characteristics of patients with metastasis and non-metastasis, the potential risk factors of VUL metastasis were analyzed. The oncological outcomes of patients with different resection range of the anterior VUL were compared. At the same time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table was used to evaluate cervical cancer patients after surgery. The relevant factors that may affect the quality of life score are included in the multiple linear regression analysis to obtain independent risk factors that affect the quality of life of the patient after surgery.
- Conditions
- Cervical Cancer
- Being tested
- Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)
- Keywords
- Cervical cancer, Radical hysterectomy, Ultrastaging, Vesicouterine ligament
- 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.
Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)Procedure or surgery
The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter).
| Study group | Role | What they receive |
|---|---|---|
| Type B resection | The patients reviced type B resection of the antierior leaf of vesicouterine ligament Receives: Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C) | |
| Type C resection | The patients reviced type C resection of the antierior leaf of vesicouterine ligament Receives: Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastatic rate of the anterior leaf of vesicouterine ligament
The metastasis rate of anterior leaf of VUL (%) = (case number of positive metastatic lesion detected by H\&E staining + case number of positive metastatic lesion diagnosed by "ultrastaging") / Total number of the patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the samesurgical team ×100%
Measured: 1 year (Postoperative pathological confirmation date)
Secondary outcomes (4)
Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL
Clinical data
Measured: 1 year after surgery
Incidence of postoperative urinary dysfunction in two groups
Follow-up and subjective description
Measured: 1 year after surgery
Postoperative quality of life scores in two groups
The Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table
Measured: 1，2，3 years after surgery
DFS
Disease-free survival
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Apr 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 460 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904977
- Sponsor's protocol ID
- SYSKY-2022-446-01
- Status last verified
- May 2023
- First submitted
- 7 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4.
PubMed 31812369Cao TT, Wen HW, Gao YN, Lyu QB, Liu HX, Wang S, Wang SY, Sun HX, Yu N, Wang HB, Li Y, Wang ZQ, Chang OH, Sun XL, Wang JL. Urodynamic assessment of bladder storage function after radical hysterectomy for cervical cancer. Chin Med J (Engl). 2020 Oct 5;133(19):2274-2280. doi: 10.1097/CM9.0000000000001014.
PubMed 32925291Querleu D, Cibula D, Abu-Rustum NR. 2017 Update on the Querleu-Morrow Classification of Radical Hysterectomy. Ann Surg Oncol. 2017 Oct;24(11):3406-3412. doi: 10.1245/s10434-017-6031-z. Epub 2017 Aug 7.
PubMed 28785898Kim CH, Soslow RA, Park KJ, Barber EL, Khoury-Collado F, Barlin JN, Sonoda Y, Hensley ML, Barakat RR, Abu-Rustum NR. Pathologic ultrastaging improves micrometastasis detection in sentinel lymph nodes during endometrial cancer staging. Int J Gynecol Cancer. 2013 Jun;23(5):964-70. doi: 10.1097/IGC.0b013e3182954da8.
PubMed 23694985Zand B, Euscher ED, Soliman PT, Schmeler KM, Coleman RL, Frumovitz M, Jhingran A, Ramondetta LM, Ramirez PT. Rate of para-aortic lymph node micrometastasis in patients with locally advanced cervical cancer. Gynecol Oncol. 2010 Dec;119(3):422-5. doi: 10.1016/j.ygyno.2010.08.012. Epub 2010 Sep 15.
PubMed 20837355Kornblith AB, Huang HQ, Walker JL, Spirtos NM, Rotmensch J, Cella D. Quality of life of patients with endometrial cancer undergoing laparoscopic international federation of gynecology and obstetrics staging compared with laparotomy: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Nov 10;27(32):5337-42. doi: 10.1200/JCO.2009.22.3529. Epub 2009 Oct 5.
PubMed 19805678Narayansingh GV, Miller ID, Sharma M, Welch CJ, Sharp L, Parkin DE, Cruickshank ME. The prognostic significance of micrometastases in node-negative squamous cell carcinoma of the vulva. Br J Cancer. 2005 Jan 31;92(2):222-4. doi: 10.1038/sj.bjc.6602343.
PubMed 15655537
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT05904977
- Acronym / sponsor ID
- SYSKY-2022-446-01
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, Radical hysterectomy, Ultrastaging, Vesicouterine ligament
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jun 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 purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary complications.
Detailed description
The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). The anterior leaf of the VUL in the type C resection group was sent to pathological biopsy separately, and the metastasis rate was further clarified by the pathological "ultrastaging" method. By comparing the clinicopathological characteristics of patients with metastasis and non-metastasis, the potential risk factors of VUL metastasis were analyzed. The oncological outcomes of patients with different resection range of the anterior VUL were compared. At the same time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table was used to evaluate cervical cancer patients after surgery. The relevant factors that may affect the quality of life score are included in the multiple linear regression analysis to obtain independent risk factors that affect the quality of life of the patient after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type B resection | – | Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)The patients reviced type B resection of the antierior leaf of vesicouterine ligament |
| Type C resection | – | Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)The patients reviced type C resection of the antierior leaf of vesicouterine ligament |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter).
Key inclusion criteria (7 listed)
- Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma)
- Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis
- Stage IA2-IIA2 ( FIGO 2018)
- Treated initially or just underwent cervical conization before
- Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team
Key exclusion criteria (6 listed)
- Not stage IA2-IIA2 ( FIGO 2018)
- History of abdominal or pelvic radiotherapy
- Evidence of metastatic disease detected by PECT, MRI or CT
- The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery
- Patients with other mailgnant tumors except cervical cancer
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 |
|---|---|---|
| Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). | Procedure or surgery | Type B resection, Type C resection |
Primary outcome
Metastatic rate of the anterior leaf of vesicouterine ligament
Time frame: 1 year (Postoperative pathological confirmation date)
The metastasis rate of anterior leaf of VUL (%) = (case number of positive metastatic lesion detected by H\&E staining + case number of positive metastatic lesion diagnosed by "ultrastaging") / Total number of the patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the samesurgical team ×100%
4 secondary outcomes
Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL
Time frame: 1 year after surgery
Incidence of postoperative urinary dysfunction in two groups
Time frame: 1 year after surgery
Postoperative quality of life scores in two groups
Time frame: 1，2，3 years after surgery
DFS
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 31812369Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4.
- Background: PubMed 32925291Cao TT, Wen HW, Gao YN, Lyu QB, Liu HX, Wang S, Wang SY, Sun HX, Yu N, Wang HB, Li Y, Wang ZQ, Chang OH, Sun XL, Wang JL. Urodynamic assessment of bladder storage function after radical hysterectomy for cervical cancer. Chin Med J (Engl). 2020 Oct 5;133(19):2274-2280. doi: 10.1097/CM9.0000000000001014.
- Background: PubMed 28785898Querleu D, Cibula D, Abu-Rustum NR. 2017 Update on the Querleu-Morrow Classification of Radical Hysterectomy. Ann Surg Oncol. 2017 Oct;24(11):3406-3412. doi: 10.1245/s10434-017-6031-z. Epub 2017 Aug 7.
- Background: PubMed 23694985Kim CH, Soslow RA, Park KJ, Barber EL, Khoury-Collado F, Barlin JN, Sonoda Y, Hensley ML, Barakat RR, Abu-Rustum NR. Pathologic ultrastaging improves micrometastasis detection in sentinel lymph nodes during endometrial cancer staging. Int J Gynecol Cancer. 2013 Jun;23(5):964-70. doi: 10.1097/IGC.0b013e3182954da8.
- Background: PubMed 20837355Zand B, Euscher ED, Soliman PT, Schmeler KM, Coleman RL, Frumovitz M, Jhingran A, Ramondetta LM, Ramirez PT. Rate of para-aortic lymph node micrometastasis in patients with locally advanced cervical cancer. Gynecol Oncol. 2010 Dec;119(3):422-5. doi: 10.1016/j.ygyno.2010.08.012. Epub 2010 Sep 15.
- Background: PubMed 19805678Kornblith AB, Huang HQ, Walker JL, Spirtos NM, Rotmensch J, Cella D. Quality of life of patients with endometrial cancer undergoing laparoscopic international federation of gynecology and obstetrics staging compared with laparotomy: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Nov 10;27(32):5337-42. doi: 10.1200/JCO.2009.22.3529. Epub 2009 Oct 5.
- Background: PubMed 15655537Narayansingh GV, Miller ID, Sharma M, Welch CJ, Sharp L, Parkin DE, Cruickshank ME. The prognostic significance of micrometastases in node-negative squamous cell carcinoma of the vulva. Br J Cancer. 2005 Jan 31;92(2):222-4. doi: 10.1038/sj.bjc.6602343.
- 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.
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 Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 6 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 15 Jun 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 Huaiwu Lu (18688395806, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastatic rate of the anterior leaf of vesicouterine ligament (time frame: 1 year (Postoperative pathological confirmation date)). 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 NCT05904977, which also lists 7 linked publications.
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 15 Jun 2023.