Cervical CancerNCT06489171
Research on Laparoscopic Fertility-Sparing Surgery in Early-Stage Cervical Cancer
An observational study of Cervical Cancer, run by Peking Union Medical College Hospital.
Trial summary
Purpose: To evaluate the oncological and obstetrical outcomes of women with early-stage cervical cancer who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT). All women with early-stage cervical cancer who planned to undergo fertility-preserved radical trachelectomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Received laparoscopic-assisted vaginal radical trachelectomy
- Type of treatment
- Surgery or procedure
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 31 Oct 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will include 132 patients with early-stage cervical cancer, who undergo laparoscopic-assisted vaginal radical trachelectomy.
Who may be able to join
- (i) were younger than 45 years old; (ii) strong desired to preserve fertility; (iii) had International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymphovascular space invasion (LVSI) positivity) to IB2; (iv) pathologically confirmed invasive cervical cancer; (v)had histology indicative of squamous cell carcinoma, adenosquamous cancer or adenocarcinoma; (vi) lacked evidence of pelvic lymph node or distant metastasis according to pelvic MRI and serum tumor markers (SCC and CA125) levels.
Who cannot join
- (i) diagnosis of cervical gastric adenocarcinoma, cervical neuroendocrine carcinoma and other special types; (ii) invasion of cervical internal orifice; (iii) had contraindication of pregnancy; (iv) incomplete clinical data; (v) radiotherapy or hysterectomy was performed after diagnostic conization.
About this study
Official title: Oncological and Obstetrical Outcomes for Fertility Preservation in Early Cervical Cancer Patient With Laparoscopic-assisted Vaginal Radical Trachelectomy
Purpose: To evaluate the oncological and obstetrical outcomes of women with early-stage cervical cancer who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT). All women with early-stage cervical cancer who planned to undergo fertility-preserved radical trachelectomy. The obstetric outcome evaluation was restricted to women with ≥12 months of follow-up and an active desire to conceive. The oncological outcome was evaluated in all patients.
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
This retrospective cohort study reported the reproductive intentions and outcomes of cervical cancer patients who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT) .The LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os".
Postoperative adjuvant chemotherapy is indicated when women have at least one of 3 intermediate risk factors: stromal invasion of more than half of the cervix, lymphovascular space invasion (LVSI), or a tumor diameter of 4 cm or greater. Platinum-based chemotherapy (combination of paclitaxel and cisplatin or carboplatin for 3 courses) was used for these women.
Women attended follow-up visits every 3 months for the first 2 years, every 6 months for the next 3 years, and annually every year thereafter. At each follow-up visit, a physical and gynecological examination and a conventional Pap smear combined with an HPV test were performed. Abdominal (including both kidneys) and pelvic ultrasound (US) and serum tumor marker (SCC antigen or CA125 for adenocarcinoma) data were also included.
When tumor recurrence was suspected based on clinical findings or imaging studies, a positron emission tomography (PET)-CT scan was performed to investigate the extent of disease. Recurrence was confirmed by a lesion on biopsy or a positive PET-CT scan. The follow-up duration was measured from the day of the operation to the day of the last follow-up, death or loss to follow-up.
- Conditions
- Cervical Cancer
- Being tested
- Received laparoscopic-assisted vaginal radical trachelectomy
- 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.
Received laparoscopic-assisted vaginal radical trachelectomyProcedure or surgery
The LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os".
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
the date of the treatment to the date of disease progression or death from any cause in the absence of progression
Measured: 5-10 years
Pregnancy rate after surgery
Postoperative patients who have successfully conceived
Measured: 5 years
Recurrence rate
The ratio of recurrent patients to the total enrolled patients
Measured: 20years
Secondary outcomes (2)
Average operation time
The length of the surgery
Measured: Intraoperative
bleeding volume
the amount of blood loss in the patient
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jan 2003
- Primary completion1 Jan 2013
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Peking Union Medical College HospitalThe 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489171
- Sponsor's protocol ID
- S-K789
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kyrgiou M, Mitra A, Paraskevaidis E. Fertility and Early Pregnancy Outcomes Following Conservative Treatment for Cervical Intraepithelial Neoplasia and Early Cervical Cancer. JAMA Oncol. 2016 Nov 1;2(11):1496-1498. doi: 10.1001/jamaoncol.2016.1839.
PubMed 27356074Martinelli F, Ditto A, Filippi F, Vinti D, Bogani G, Leone Roberti Maggiore U, Evangelista M, Signorelli M, Chiappa V, Lopez S, Somigliana E, Raspagliesi F. Conization and lymph node evaluation as a fertility-sparing treatment for early stage cervical cancer. Int J Gynecol Cancer. 2021 Mar;31(3):457-461. doi: 10.1136/ijgc-2020-001740.
PubMed 33649014Kyrgiou M, Athanasiou A, Arbyn M, Lax SF, Raspollini MR, Nieminen P, Carcopino X, Bornstein J, Gultekin M, Paraskevaidis E. Terminology for cone dimensions after local conservative treatment for cervical intraepithelial neoplasia and early invasive cervical cancer: 2022 consensus recommendations from ESGO, EFC, IFCPC, and ESP. Lancet Oncol. 2022 Aug;23(8):e385-e392. doi: 10.1016/S1470-2045(22)00191-7.
PubMed 35901834Fokom Domgue J, Schmeler KM. Conservative management of cervical cancer: Current status and obstetrical implications. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:79-92. doi: 10.1016/j.bpobgyn.2018.06.009. Epub 2018 Jun 28.
PubMed 30029960Cao 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 24169350
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological and Obstetrical Outcomes for Fertility Preservation in Early Cervical Cancer Patient With Laparoscopic-assisted Vaginal Radical Trachelectomy
- ClinicalTrials.gov ID
- NCT06489171
- Acronym / sponsor ID
- S-K789
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Jul 2024 (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 oncological and obstetrical outcomes of women with early-stage cervical cancer who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT). All women with early-stage cervical cancer who planned to undergo fertility-preserved radical trachelectomy. The obstetric outcome evaluation was restricted to women with ≥12 months of follow-up and an active desire to conceive. The oncological outcome was evaluated in all patients.
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
This retrospective cohort study reported the reproductive intentions and outcomes of cervical cancer patients who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT) .The LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os".
Postoperative adjuvant chemotherapy is indicated when women have at least one of 3 intermediate risk factors: stromal invasion of more than half of the cervix, lymphovascular space invasion (LVSI), or a tumor diameter of 4 cm or greater. Platinum-based chemotherapy (combination of paclitaxel and cisplatin or carboplatin for 3 courses) was used for these women.
Women attended follow-up visits every 3 months for the first 2 years, every 6 months for the next 3 years, and annually every year thereafter. At each follow-up visit, a physical and gynecological examination and a conventional Pap smear combined with an HPV test were performed. Abdominal (including both kidneys) and pelvic ultrasound (US) and serum tumor marker (SCC antigen or CA125 for adenocarcinoma) data were also included.
When tumor recurrence was suspected based on clinical findings or imaging studies, a positron emission tomography (PET)-CT scan was performed to investigate the extent of disease. Recurrence was confirmed by a lesion on biopsy or a positive PET-CT scan. The follow-up duration was measured from the day of the operation to the day of the last follow-up, death or loss to follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include 132 patients with early-stage cervical cancer, who undergo laparoscopic-assisted vaginal radical trachelectomy.
Key inclusion criteria (1 listed)
- (i) were younger than 45 years old; (ii) strong desired to preserve fertility; (iii) had International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymphovascular space invasion (LVSI) positivity) to IB2; (iv) pathologically confirmed invasive cervical cancer; (v)had histology indicative of squamous cell carcinoma, adenosquamous cancer or adenocarcinoma; (vi) lacked evidence of pelvic lymph node or distant metastasis according to pelvic MRI and serum tumor markers (SCC and CA125) levels.
Key exclusion criteria (1 listed)
- (i) diagnosis of cervical gastric adenocarcinoma, cervical neuroendocrine carcinoma and other special types; (ii) invasion of cervical internal orifice; (iii) had contraindication of pregnancy; (iv) incomplete clinical data; (v) radiotherapy or hysterectomy was performed after diagnostic conization.
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 |
|---|---|---|
| Received laparoscopic-assisted vaginal radical trachelectomyThe LAVRT procedure began with laparoscopic pelvic lymphadenectomy, and all lymph nodes were removed for frozen pathological analysis. The laparoscopic-assisted vaginal radical trachelectomy procedure was continued only if the nodes were negative. The pararectal pouch was revealed, and the uterine arteries were divided from their origin to the internal iliac artery. The ureters were freed from the posterior leaf of the broad ligament down to the level where they entered the ureteral tunnel and then displaced laterally. The uterosacral ligaments, cardinal ligaments, and parametrial portions were then divided and dissected. The section of the procedure was performed laparoscopically. The vaginal epithelium was circumferentially incised approximately 3 cm distal to the endocervix. Frozen section analysis confirmed no cancer involvement at the endocervical or vaginal margin. The vaginal mucosa was sutured to the cervical stump to form a "new cervical os". | Procedure or surgery | – |
Primary outcome
Progression-Free Survival
Time frame: 5-10 years
the date of the treatment to the date of disease progression or death from any cause in the absence of progression
Pregnancy rate after surgery
Time frame: 5 years
Postoperative patients who have successfully conceived
Recurrence rate
Time frame: 20years
The ratio of recurrent patients to the total enrolled patients
2 secondary outcomes
Average operation time
Time frame: Intraoperative
bleeding volume
Time frame: Intraoperative
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 5 Jul 2024.
- Background: PubMed 27356074Kyrgiou M, Mitra A, Paraskevaidis E. Fertility and Early Pregnancy Outcomes Following Conservative Treatment for Cervical Intraepithelial Neoplasia and Early Cervical Cancer. JAMA Oncol. 2016 Nov 1;2(11):1496-1498. doi: 10.1001/jamaoncol.2016.1839.
- Background: PubMed 33649014Martinelli F, Ditto A, Filippi F, Vinti D, Bogani G, Leone Roberti Maggiore U, Evangelista M, Signorelli M, Chiappa V, Lopez S, Somigliana E, Raspagliesi F. Conization and lymph node evaluation as a fertility-sparing treatment for early stage cervical cancer. Int J Gynecol Cancer. 2021 Mar;31(3):457-461. doi: 10.1136/ijgc-2020-001740.
- Background: PubMed 35901834Kyrgiou M, Athanasiou A, Arbyn M, Lax SF, Raspollini MR, Nieminen P, Carcopino X, Bornstein J, Gultekin M, Paraskevaidis E. Terminology for cone dimensions after local conservative treatment for cervical intraepithelial neoplasia and early invasive cervical cancer: 2022 consensus recommendations from ESGO, EFC, IFCPC, and ESP. Lancet Oncol. 2022 Aug;23(8):e385-e392. doi: 10.1016/S1470-2045(22)00191-7.
- Background: PubMed 30029960Fokom Domgue J, Schmeler KM. Conservative management of cervical cancer: Current status and obstetrical implications. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:79-92. doi: 10.1016/j.bpobgyn.2018.06.009. Epub 2018 Jun 28.
- Results publication: 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.
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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 record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Peking Union Medical College 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 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: finished, as of the sponsor's last update on 5 Jul 2024. 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?
Progression-Free Survival (time frame: 5-10 years). The study lists 3 primary outcomes in all. 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 NCT06489171, which also lists 5 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 5 Jul 2024.