Endometrial CarcinomaNCT03877627
The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma
A study testing Pelvic and Peritoneal Lymphadenectomy in people with Endometrial Carcinoma and Lymphadenectomy, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
The aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management. Read more about this study
- Who is it for?
- Ages 10 to 90 years, women only
- Conditions the study is for
- Endometrial Carcinoma, Lymphadenectomy
- What is being tested?
- Pelvic and Peritoneal Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Apr 2023
- 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 10 to 90 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Females who are diagnosed with endometrial carcinoma;
- Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease;
- Patients who are agreed to participated in this prospective cohort study.
Who cannot join
- Patients who still have the will to have pregnancy;
- Patients who have other diseases or heavy injuries that will interfere with the results;
- Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.
Read the detailed description
The clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between April 2019 and April 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.
- Conditions
- Endometrial Carcinoma, Lymphadenectomy
- Being tested
- Pelvic and Peritoneal Lymphadenectomy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic and Peritoneal LymphadenectomyProcedure or surgery
Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Negative 1 | No intervention | Patients in this arm will not undergo Pelvic and Peritoneal Lymphadenectomy. |
| Negative 2 | Experimental | Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy. Receives: Procedure: Pelvic and Peritoneal Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number (s) of pelvic and abdominal lymph node metastasis
the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
Measured: 1 year during the perioperative period
the percentage (%) of pelvic and abdominal lymph node metastasis
the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
Measured: 1 year during the perioperative period
the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis
by performing chi-square test by SPSS 17.0，we plan to calculate the coincidence rate of three clinical examination
Measured: 1 year during the perioperative period
the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients
by setting up the control group and experimental group and conducting follow-up，we are determined to know whether pelvic lymphadenectomy would influence the prognosis of endometrial carcinoma
Measured: 1 year during the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Apr 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877627
- Sponsor's protocol ID
- SAHoWMU-CR2019-07-102
- Status last verified
- Oct 2020
- First submitted
- 10 Mar 2019
- Last updated
- 29 Oct 2020
- 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 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT03877627
- Acronym / sponsor ID
- SAHoWMU-CR2019-07-102
- Conditions
- Endometrial Carcinoma, Lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 15 Mar 2019 (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 aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.
Detailed description
The clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between April 2019 and April 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
| Arm | Type | Receives |
|---|---|---|
| Negative 1 | No intervention | –Patients in this arm will not undergo Pelvic and Peritoneal Lymphadenectomy. |
| Negative 2 | Experimental | Procedure: Pelvic and Peritoneal LymphadenectomyPatients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Females who are diagnosed with endometrial carcinoma;
- Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease;
- Patients who are agreed to participated in this prospective cohort study.
Key exclusion criteria (3 listed)
- Patients who still have the will to have pregnancy;
- Patients who have other diseases or heavy injuries that will interfere with the results;
- Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
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 |
|---|---|---|
| Pelvic and Peritoneal LymphadenectomyPatients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma. | Procedure or surgery | Negative 2 |
Primary outcome
the number (s) of pelvic and abdominal lymph node metastasis
Time frame: 1 year during the perioperative period
the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
the percentage (%) of pelvic and abdominal lymph node metastasis
Time frame: 1 year during the perioperative period
the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis
Time frame: 1 year during the perioperative period
by performing chi-square test by SPSS 17.0，we plan to calculate the coincidence rate of three clinical examination
the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients
Time frame: 1 year during the perioperative period
by setting up the control group and experimental group and conducting follow-up，we are determined to know whether pelvic lymphadenectomy would influence the prognosis of endometrial carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic and Peritoneal Lymphadenectomy in people with Endometrial Carcinoma and Lymphadenectomy, run by Second Affiliated Hospital of Wenzhou Medical University.
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 3 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 29 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu ZHAO, Ph.D (13777760306, zhaoyu196035@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number (s) of pelvic and abdominal lymph node metastasis (time frame: 1 year during the perioperative period). The study lists 4 primary outcomes in all. 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 29 Oct 2020.