Endometrial NeoplasmsEC-02NCT01820884
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma
A study testing TH, TH/BSO and BPLND in people with Endometrial Neoplasms, run by Ding Ma at 3 sites in China.
Trial summary
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- TH, TH/BSO and BPLND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2012to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- FIGO stage: ⅠA, endometrial carcinoma;
- Female, Chinese women;
- premenopausal women；
- ≤ 50 years old;
- Pathological diagnosis by curettage/hysteroscopy : G1
- No prior treatment;
- Provide written informed consent.
Who cannot join
- The suspicious metastasis of ovarian;
- Family history of ovarian cancer;
- Suffering from other malignancies;
- Concurrently participating in other clinical trials;
- Unable or unwilling to sign informed consents;
- Unable or unwilling to abide by protocol.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006
Qilu Hospital，Shandong University
Jinan, Shandong, 250012
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.
- Conditions
- Endometrial Neoplasms
- Being tested
- TH, TH/BSO, BPLND
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THProcedure or surgery
Total hysterectomy
TH/BSOProcedure or surgery
Total hysterectomy and bilateral salpingo-oophorectomy
BPLNDProcedure or surgery
bilateral pelvic and para-aortic lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Total Hysterectomy (TH) | Experimental | Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND). Receives: Procedure: TH; Procedure: BPLND |
| TH and bilateral salpingo-oophorectomy (TH/BSO) | Active comparator | Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection. Receives: Procedure: TH/BSO; Procedure: BPLND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: 3-year DFS
Secondary outcomes (3)
Clinical gynecologic endocrine function
To observe the level of female hormone，i.e., estrogen, FSH, LH
Measured: 1-year period
Quality of Life
Measured: 3-year period
Overall Survival (OS)
Measured: 3-year OS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ding Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University, Huazhong University of Science and Technology, Zhejiang University
- Responsible party
- Sponsor-investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Beihua Kong, MD, PhD, Study chair, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820884
- Sponsor's protocol ID
- 2012-GYN/EC-02
- Acronym
- EC-02
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2013
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT01820884
- Acronym / sponsor ID
- EC-02 / 2012-GYN/EC-02
- Conditions
- Endometrial Neoplasms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ding MaUniversity, hospital or other
- Collaborators
- Shandong University, Huazhong University of Science and Technology, Zhejiang University
- Study start
- Nov 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2013 (estimated)
- 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 randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hysterectomy (TH) | Experimental | Procedure: TH, Procedure: BPLNDPatients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND). |
| TH and bilateral salpingo-oophorectomy (TH/BSO) | Active comparator | Procedure: TH/BSO, Procedure: BPLNDPatients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- FIGO stage: ⅠA, endometrial carcinoma;
- Female, Chinese women;
- premenopausal women；
- ≤ 50 years old;
- Pathological diagnosis by curettage/hysteroscopy : G1
Key exclusion criteria (6 listed)
- The suspicious metastasis of ovarian;
- Family history of ovarian cancer;
- Suffering from other malignancies;
- Concurrently participating in other clinical trials;
- Unable or unwilling to sign informed consents;
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 |
|---|---|---|
| THTotal hysterectomy | Procedure or surgery | Total Hysterectomy (TH) |
| TH/BSOTotal hysterectomy and bilateral salpingo-oophorectomy | Procedure or surgery | TH and bilateral salpingo-oophorectomy (TH/BSO) |
| BPLNDbilateral pelvic and para-aortic lymph node dissection | Procedure or surgery | TH and bilateral salpingo-oophorectomy (TH/BSO), Total Hysterectomy (TH) |
Primary outcome
Disease-free survival (DFS)
Time frame: 3-year DFS
3 secondary outcomes
Clinical gynecologic endocrine function
Time frame: 1-year period
Quality of Life
Time frame: 3-year period
Overall Survival (OS)
Time frame: 3-year OS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
Beihua Kong, MD, PhD study chair
Shandong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TH, TH/BSO and BPLND in people with Endometrial Neoplasms, run by Ding Ma at 3 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Disease-free survival (DFS) (time frame: 3-year DFS). 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 2 Apr 2024.