Endometrial CancerNCT03804463
The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
A study testing endometrial cancer radical surgery, fertility-sparing surgery and ovarian preservation surgery in people with Endometrial Cancer, run by Min Wang at 1 site in China.
Trial summary
Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- endometrial cancer radical surgery, fertility-sparing surgery and ovarian preservation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2019to 31 Dec 2021
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal women, age ≤ 50 years
- Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
- Clinical consideration of IA (<1/2 muscle infiltration);
- First-time treatment
- The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.
Who cannot join
- At the same time participate in other clinical trials;
- Can not tolerate surgery;
- Ovarian suspicious metastasis;
- Have a family history of ovarian cancer;
- Incorporate other malignant tumors;
- Preoperative CA125 abnormal persons
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospitaol of China Medical University
Shenyang, Liaoning, 110004
Min Wang, PHD, 18940251222, wm21st@126.com
About this study
Official title: The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.
Read the detailed description
Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.
- Conditions
- Endometrial Cancer
- Being tested
- endometrial cancer radical surgery, fertility-sparing surgery, ovarian preservation surgery
- Keywords
- Preservation of fertility surger, ovarian preservation, endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial cancer radical surgeryProcedure or surgery
Take hysterectomy and bilateral adnexectomy.
fertility-sparing surgeryProcedure or surgery
Take endometrectomy , preserve uterus and bilateral ovaries.
ovarian preservation surgeryProcedure or surgery
Take hysterectomy,preserve bilateral ovaries.
| Study group | Role | What they receive |
|---|---|---|
| radical surgery group | Experimental | Endometrial cancer radical surgery to be administered in this arm. Receives: Procedure: endometrial cancer radical surgery |
| fertility preservation group | Experimental | Fertility-sparing surgery to be administered in this arm. Receives: Procedure: fertility-sparing surgery |
| ovarian preservation group | Experimental | Ovarian preservation surgery to be administered in this arm. Receives: Procedure: ovarian preservation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total survival Time
calculate the time from patients enter the group to death
Measured: 6 months
Secondary outcomes (3)
the change of Ovarian volume
measure the ovarian volume dynamically by ultrasonography
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
the change of endocrine function evaluation
measure the endocrine function(hormone level) dynamically by blood detection
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Progression Free Survival
calculate the time from patients enter the group to tumor progression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start10 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Wang
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University
- Responsible party
- Sponsor-investigator, Min Wang, Shengjing Hospital
- Investigators
- Min Wang, PHD., Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804463
- Sponsor's protocol ID
- 2017PS017K
- Status last verified
- Jan 2019
- First submitted
- 4 Jun 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03804463
- Acronym / sponsor ID
- 2017PS017K
- Conditions
- Endometrial Cancer
- Keywords
- Preservation of fertility surger, ovarian preservation, endometrial cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Min WangUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University
- Study start
- 10 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Jan 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.
Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.
Detailed description
Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| radical surgery group | Experimental | Procedure: endometrial cancer radical surgeryEndometrial cancer radical surgery to be administered in this arm. |
| fertility preservation group | Experimental | Procedure: fertility-sparing surgeryFertility-sparing surgery to be administered in this arm. |
| ovarian preservation group | Experimental | Procedure: ovarian preservation surgeryOvarian preservation surgery to be administered in this arm. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Premenopausal women, age ≤ 50 years
- Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
- Clinical consideration of IA (<1/2 muscle infiltration);
- First-time treatment
- The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.
Key exclusion criteria (6 listed)
- At the same time participate in other clinical trials;
- Can not tolerate surgery;
- Ovarian suspicious metastasis;
- Have a family history of ovarian cancer;
- Incorporate other malignant tumors;
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 |
|---|---|---|
| endometrial cancer radical surgeryTake hysterectomy and bilateral adnexectomy. | Procedure or surgery | radical surgery group |
| fertility-sparing surgeryTake endometrectomy , preserve uterus and bilateral ovaries. | Procedure or surgery | fertility preservation group |
| ovarian preservation surgeryTake hysterectomy,preserve bilateral ovaries. | Procedure or surgery | ovarian preservation group |
Primary outcome
Total survival Time
Time frame: 6 months
calculate the time from patients enter the group to death
3 secondary outcomes
the change of Ovarian volume
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
the change of endocrine function evaluation
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Progression Free Survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Min Wang, PHD. study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial cancer radical surgery, fertility-sparing surgery and ovarian preservation surgery in people with Endometrial Cancer, run by Min Wang 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 5 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 Jan 2019. 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 Min Wang, PHD. (18940251222, wm21st@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total survival Time (time frame: 6 months). 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 15 Jan 2019.