Uterine Cervical NeoplasmsNCT03738969
Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer
An observational study of Uterine Cervical Neoplasms and Laparotomy, run by Lei Li at 1 site in China.
Trial summary
This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Laparotomy, Laparoscopy
- What is being tested?
- Laparotomic radical hysterectomy and Laparoscopic radical hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 23 Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients pathological confirmed as uterine cervival cancer and receiving radical hysterectomy or trachelectomy would been included.
Who may be able to join
- Pathological confirmed as uterine cervical cancer
- Having definite clinical information
- Having received radical hysterectomy or trachelectomy
Who cannot join
- Not satisfying any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 13911988831 ext. 86, lileigh@163.com
About this study
Official title: Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer
This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.
- Conditions
- Uterine Cervical Neoplasms, Laparotomy, Laparoscopy, Survival, Mortality, Recurrence
- Being tested
- Laparotomic radical hysterectomy, Laparoscopic radical hysterectomy
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparotomic radical hysterectomyProcedure or surgery
Radical hysterectomy applied by laparotomy
Laparoscopic radical hysterectomyProcedure or surgery
Radical hysterectomy applied by laparoscopic
| Study group | Role | What they receive |
|---|---|---|
| Laparotomy group | Patients in this group accepted laparotomic radical hysterectomy for cervical cancer. Receives: Procedure: Laparotomic radical hysterectomy | |
| Laparoscopy group | Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer. Receives: Procedure: Laparoscopic radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse
Measured: Five years
Secondary outcomes (2)
Overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.
Measured: Five years
Disease-free survival
In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Nov 2018
- Primary completion23 Dec 2022 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738969
- Sponsor's protocol ID
- SACCC
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data will be available to all researchers on the public websites
Publications
Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.
PubMed 32819996
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer
- ClinicalTrials.gov ID
- NCT03738969
- Acronym / sponsor ID
- SACCC
- Conditions
- Uterine Cervical Neoplasms, Laparotomy, Laparoscopy, Survival, Mortality, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 13 Nov 2018 (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.
This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparotomy group | – | Procedure: Laparotomic radical hysterectomyPatients in this group accepted laparotomic radical hysterectomy for cervical cancer. |
| Laparoscopy group | – | Procedure: Laparoscopic radical hysterectomyPatients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients pathological confirmed as uterine cervival cancer and receiving radical hysterectomy or trachelectomy would been included.
Key inclusion criteria (3 listed)
- Pathological confirmed as uterine cervical cancer
- Having definite clinical information
- Having received radical hysterectomy or trachelectomy
Key exclusion criteria (1 listed)
- Not satisfying any of the inclusion criteria
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 |
|---|---|---|
| Laparotomic radical hysterectomyRadical hysterectomy applied by laparotomy | Procedure or surgery | Laparotomy group |
| Laparoscopic radical hysterectomyRadical hysterectomy applied by laparoscopic | Procedure or surgery | Laparoscopy group |
Primary outcome
Progression-free survival
Time frame: Five years
Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse
2 secondary outcomes
Overall survival
Time frame: Five years
Disease-free survival
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 32819996Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.
- Individual participant dataSharing planned: Yes. All the data will be available to all researchers on the public websites
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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 Uterine Cervical Neoplasms and Laparotomy, run by Lei Li 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 3 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 14 Nov 2018. 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 Lei Li, M.D. (13911988831 ext. 86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Five years). 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 NCT03738969, which also lists 1 linked publication.
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 14 Nov 2018.