Cervical CancerNCT05806125
Clinical Value of the Fertility-preserving Surgery in 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
Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Dec 2024
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries.
Who may be able to join
- 1. Female, ≥20 years old; 2. Clinical diagnosis of cervical cancer; 3. Received radical trachelectomy; 4. Have good compliance, and can complete the enrollment by the requirements of the trial; 5. Sign informed consent and agree to the collection and use of their data.
Who cannot join
- 1. Have received other anti-tumor treatments or received tumor surgery before enrollment; 2. With other malignant tumors; 3. With uncontrollable neurological, psychiatric, or mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Huaiwu Lu, +8618688395806, luhuaiwu@mail.sysu.edu.cn
About this study
Official title: Clinical Value of the Fertility-preserving Surgery in Cervical Cancer -- the Feasibility of the 'Cuff-sleeve' Suture Method in the Ascending Branch of Uterine Artery Preserved Radical Trachelectomy
Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. Patients in the postoperative group will undergo computed tomography angiography (CTA) after surgery and patients in the preoperative group will undergo CTA before RT. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.
Read the detailed description
Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery, at Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The investigators attribute the uterine artery occlusion to the inevitable injury of the remaining uterine arteries during the ligation of the descending branch of the uterine artery and continuous or intermittent suturing. Hence, the investigators will carefully skeletonize the three branches of the uterine artery, ligates the vaginal and cervical branches, and preserves the ascending branch of the uterine artery under direct vision. Furthermore, a new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. All patients in the postoperative group will undergo computed tomography angiography (CTA) to evaluate the status of the preserved ascending branch and the residual uterine blood supply pattern after surgery. Patients in the preoperative group will undergo CTA before RT to determine the uterine blood supply pattern in healthy individuals. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. The CTA data are mainly analyzed to determine the arteries supplying the uterus. The investigators consider a vessel as a supplying artery only when it is continuous from its origin up to the entry into the uterus and then branches. The uterine blood supply in patients is divided into three patterns based on the supplying vessels. The first is the ovarian artery-supplying pattern, wherein the residual uterus is supplied only by the ovarian arteries. The second is the hybrid-supplying pattern, in which an ovarian artery or a newly formed artery supplied the residual uterus along with the contralateral uterine artery. The third is the uterine artery-supplying pattern, wherein the residual uterus is supplied only by the uterine arteries. Furthermore, the diameter of the visualized supplying vessels is recorded. The diameters of the uterine and newly formed arteries are measured 2 cm before they enter the corpus uteri. However, the ovarian artery diameter is measured at its origin from the aorta ventralis, beside the external iliac artery, and 2 cm before it enters the corpus uteri since the ovarian arteries are convoluted. Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.
- Conditions
- Cervical Cancer
- Keywords
- computed tomography angiography, diameter of the supplying artery, fertility outcome, uterine blood supply pattern
- 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.
| Study group | Role | What they receive |
|---|---|---|
| the postoperative group | All patients in the postoperative group will undergo computed tomography angiography (CTA) to evaluate the status of the preserved ascending branch and the residual uterine blood supply pattern after surgery. | |
| the preoperative group | Patients in the preoperative group will undergo CTA before RT to determine the uterine blood supply pattern in healthy individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pattern of the uterine blood supply
The first is the ovarian artery-supplying pattern, wherein the residual uterus is supplied only by the ovarian arteries. The second is the hybrid-supplying pattern, in which an ovarian artery or a newly formed artery supplied the residual uterus along with the contralateral uterine artery. The third is the uterine artery-supplying pattern, wherein the residual uterus is supplied only by the uterine arteries.
Measured: The postoperative group will undergo CTA 3 months after surgery while the preoperative group will undergo CTA 1 week before the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Huaiwu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806125
- Sponsor's protocol ID
- SYSKY-2022-038-01
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- 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 31812369Koh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Clark R, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jan;17(1):64-84. doi: 10.6004/jnccn.2019.0001.
PubMed 30659131Dargent D, Martin X, Sacchetoni A, Mathevet P. Laparoscopic vaginal radical trachelectomy: a treatment to preserve the fertility of cervical carcinoma patients. Cancer. 2000 Apr 15;88(8):1877-82.
PubMed 10760765Cao DY, Yang JX, Wu XH, Chen YL, Li L, Liu KJ, Cui MH, Xie X, Wu YM, Kong BH, Zhu GH, Xiang Y, Lang JH, Shen K; China Gynecologic Oncology Group. Comparisons of vaginal and abdominal radical trachelectomy for early-stage cervical cancer: preliminary results of a multi-center research in China. Br J Cancer. 2013 Nov 26;109(11):2778-82. doi: 10.1038/bjc.2013.656. Epub 2013 Oct 29.
PubMed 24169350Bentivegna E, Maulard A, Pautier P, Chargari C, Gouy S, Morice P. Fertility results and pregnancy outcomes after conservative treatment of cervical cancer: a systematic review of the literature. Fertil Steril. 2016 Oct;106(5):1195-1211.e5. doi: 10.1016/j.fertnstert.2016.06.032. Epub 2016 Jul 16.
PubMed 27430207Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3.
PubMed 18308255
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of the Fertility-preserving Surgery in Cervical Cancer -- the Feasibility of the 'Cuff-sleeve' Suture Method in the Ascending Branch of Uterine Artery Preserved Radical Trachelectomy
- ClinicalTrials.gov ID
- NCT05806125
- Acronym / sponsor ID
- SYSKY-2022-038-01
- Conditions
- Cervical Cancer
- Keywords
- computed tomography angiography, diameter of the supplying artery, fertility outcome, uterine blood supply pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Apr 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.
Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. Patients in the postoperative group will undergo computed tomography angiography (CTA) after surgery and patients in the preoperative group will undergo CTA before RT. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.
Detailed description
Purpose: To evaluate the clinical value of preserving the ascending branch of the uterine artery in improving the uterine blood supply after radical trachelectomy (RT). Method: This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery, at Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The investigators attribute the uterine artery occlusion to the inevitable injury of the remaining uterine arteries during the ligation of the descending branch of the uterine artery and continuous or intermittent suturing. Hence, the investigators will carefully skeletonize the three branches of the uterine artery, ligates the vaginal and cervical branches, and preserves the ascending branch of the uterine artery under direct vision. Furthermore, a new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries. Study groups: The patients will be categorized into two groups. All patients in the postoperative group will undergo computed tomography angiography (CTA) to evaluate the status of the preserved ascending branch and the residual uterine blood supply pattern after surgery. Patients in the preoperative group will undergo CTA before RT to determine the uterine blood supply pattern in healthy individuals. Data collection: Data regarding individual patient characteristics, International Federation of Gynecology and Obstetrics (FIGO) stage, histologic subtype, lymphovascular space involvement (LVSI) status, recurrence, CTA data, fertility results, and obstetric outcomes will be collected for the patients in the postoperative group. The CTA findings of the preoperative group will be obtained. The CTA data are mainly analyzed to determine the arteries supplying the uterus. The investigators consider a vessel as a supplying artery only when it is continuous from its origin up to the entry into the uterus and then branches. The uterine blood supply in patients is divided into three patterns based on the supplying vessels. The first is the ovarian artery-supplying pattern, wherein the residual uterus is supplied only by the ovarian arteries. The second is the hybrid-supplying pattern, in which an ovarian artery or a newly formed artery supplied the residual uterus along with the contralateral uterine artery. The third is the uterine artery-supplying pattern, wherein the residual uterus is supplied only by the uterine arteries. Furthermore, the diameter of the visualized supplying vessels is recorded. The diameters of the uterine and newly formed arteries are measured 2 cm before they enter the corpus uteri. However, the ovarian artery diameter is measured at its origin from the aorta ventralis, beside the external iliac artery, and 2 cm before it enters the corpus uteri since the ovarian arteries are convoluted. Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the postoperative group | – | –All patients in the postoperative group will undergo computed tomography angiography (CTA) to evaluate the status of the preserved ascending branch and the residual uterine blood supply pattern after surgery. |
| the preoperative group | – | –Patients in the preoperative group will undergo CTA before RT to determine the uterine blood supply pattern in healthy individuals. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include 100 patients with early-stage cervical cancer, who undergo RT with the preservation of the ascending branch of the uterine artery. A new skill called the "cuff-sleeve" suture method is introduced to wrap the vagina around the stump cervix, wherein they are sutured using a 2-0 absorbable suture by placing two cross-stitches in the anterior and posterior wall, respectively, without piercing the cervical mucosa layer or damaging the uterine arteries.
Key inclusion criteria (1 listed)
- 1. Female, ≥20 years old; 2. Clinical diagnosis of cervical cancer; 3. Received radical trachelectomy; 4. Have good compliance, and can complete the enrollment by the requirements of the trial; 5. Sign informed consent and agree to the collection and use of their data.
Key exclusion criteria (1 listed)
- 1. Have received other anti-tumor treatments or received tumor surgery before enrollment; 2. With other malignant tumors; 3. With uncontrollable neurological, psychiatric, or mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The pattern of the uterine blood supply
Time frame: The postoperative group will undergo CTA 3 months after surgery while the preoperative group will undergo CTA 1 week before the surgery.
The first is the ovarian artery-supplying pattern, wherein the residual uterus is supplied only by the ovarian arteries. The second is the hybrid-supplying pattern, in which an ovarian artery or a newly formed artery supplied the residual uterus along with the contralateral uterine artery. The third is the uterine artery-supplying pattern, wherein the residual uterus is supplied only by the uterine arteries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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 30659131Koh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Clark R, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jan;17(1):64-84. doi: 10.6004/jnccn.2019.0001.
- Background: PubMed 10760765Dargent D, Martin X, Sacchetoni A, Mathevet P. Laparoscopic vaginal radical trachelectomy: a treatment to preserve the fertility of cervical carcinoma patients. Cancer. 2000 Apr 15;88(8):1877-82.
- Background: PubMed 24169350Cao DY, Yang JX, Wu XH, Chen YL, Li L, Liu KJ, Cui MH, Xie X, Wu YM, Kong BH, Zhu GH, Xiang Y, Lang JH, Shen K; China Gynecologic Oncology Group. Comparisons of vaginal and abdominal radical trachelectomy for early-stage cervical cancer: preliminary results of a multi-center research in China. Br J Cancer. 2013 Nov 26;109(11):2778-82. doi: 10.1038/bjc.2013.656. Epub 2013 Oct 29.
- Background: PubMed 27430207Bentivegna E, Maulard A, Pautier P, Chargari C, Gouy S, Morice P. Fertility results and pregnancy outcomes after conservative treatment of cervical cancer: a systematic review of the literature. Fertil Steril. 2016 Oct;106(5):1195-1211.e5. doi: 10.1016/j.fertnstert.2016.06.032. Epub 2016 Jul 16.
- Background: PubMed 18308255Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3.
- 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.
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
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 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pattern of the uterine blood supply (time frame: The postoperative group will undergo CTA 3 months after surgery while the preoperative group will undergo CTA 1 week before the surgery.). 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 NCT05806125, which also lists 6 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 10 Apr 2023.