Hydatidiform MoleNCT03785574
Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
A study testing Follow up and chemotherapy in people with Hydatidiform Mole and Gestational Trophoblastic Neoplasia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Hydatidiform Mole, Gestational Trophoblastic Neoplasia
- What is being tested?
- Follow up and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2018to 1 Sep 2030
- 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 Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligible patients have to meet all of the following criteria:
- Pathologically confirmed HM.
- The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
- The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
- The patients are willing to compliant with the study protocol and be followed up at regular intervals.
- The patients agree to sign an informed consent form.
Who cannot join
- The patients with a previous history of lung nodules.
- The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
- The patients have undergone prophylactic hysterectomy or chemotherapy.
- Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
- Patients have immunosuppressive diseases or take immunosuppressants.
- Patients are participating in other clinical trials at same time.
- Patients were unable or unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Weiguo Lv
Hangzhou, Zhejiang
Weiguo Lv, Doctor, 8657187061501, lixsure@163.com
About this study
Official title: Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). Lung nodule <1.0cm will directly treated as group C
Read the detailed description
The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical characteristics of patients were compared, especially chemotherapy cycles to achieve hCG normalization and failure to first-line chemotherapy.
Lung nodule <1.0cm will directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)
- Being tested
- Follow up, chemotherapy
- Keywords
- Pulmonary Nodule, Chemotherapy, Chorionic Gonadotrophin
- Medical subject headings
- Hydatidiform Mole, Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
Also called not chemotherapy immediately
the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
chemotherapyDrug
Also called mtx for low risk
First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
| Study group | Role | What they receive |
|---|---|---|
| A:chemotherapy immediately | Active comparator | Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO Receives: Drug: chemotherapy |
| B:follow up | Experimental | B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy.
B2: follow up until hCG level declined to normal spontaneously. Receives: Other: Follow up; Drug: chemotherapy |
| C: lung nodule diameter <1.0 cm | Experimental | C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously. Receives: Other: Follow up; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemotherapy cycles
the efficacy and number of treatment cycles in the chemotherapy group
Measured: 120 months
hCG declined to normal spontaneously of group B
the spontaneous regression rate in Group B
Measured: 120 months
Secondary outcomes (2)
follow up of group A , B and C
the proportion of spontaneous regression in the follow-up groups, progression-free survival (PFS) and overall survival (OS) in the chemotherapy group
Measured: 240 months
lung nodules
the changes of lung nodules
Measured: 240 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start24 Dec 2018
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatidiform MoleStudies 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
- Model description
- lung nodule ≥1.0cm were randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). A:B=1:2，the sample size of group A and group B was 30 in total. Lung nodule \<1.0cm will be directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2), it is an observation study and the sample volume depends on the enrolling time of group A and B.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Tongji Hospital Affiliated to Tongji Medical College of HUST, The First People's Hospital of Yunnan, Tianjin Central Hospital of Gynecology Obstetrics, Women and Children's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Hangzhou Fuyang Women And Children Hospital, Zhejiang Provincial Tongde Hospital, Shaoxing Shangyu Women And Children Hospital, Huzhou Maternity and Child Health Care Hospital
- Responsible party
- Principal investigator, Lixiao, Women's Hospital School Of Medicine Zhejiang University
- Investigators
- Xing Xie, Principal investigator, Women's Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785574
- Sponsor's protocol ID
- CSEM 012
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2018
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03785574
- Acronym / sponsor ID
- CSEM 012
- Keywords
- Pulmonary Nodule, Chemotherapy, Chorionic Gonadotrophin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Tongji Hospital Affiliated to Tongji Medical College of HUST, The First People's Hospital of Yunnan, Tianjin Central Hospital of Gynecology Obstetrics, Women and Children's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Hangzhou Fuyang Women And Children Hospital, Zhejiang Provincial Tongde Hospital, Shaoxing Shangyu Women And Children Hospital, Huzhou Maternity and Child Health Care Hospital
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 24 Dec 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.
The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). Lung nodule <1.0cm will directly treated as group C
Detailed description
The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical characteristics of patients were compared, especially chemotherapy cycles to achieve hCG normalization and failure to first-line chemotherapy.
Lung nodule <1.0cm will directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- lung nodule ≥1.0cm were randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). A:B=1:2，the sample size of group A and group B was 30 in total. Lung nodule <1.0cm will be directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2), it is an observation study and the sample volume depends on the enrolling time of group A and B.
| Arm | Type | Receives |
|---|---|---|
| A:chemotherapy immediately | Active comparator | Drug: chemotherapyTreated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO |
| B:follow up | Experimental | Other: Follow up, Drug: chemotherapyB1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. B2: follow up until hCG level declined to normal spontaneously. |
| C: lung nodule diameter <1.0 cm | Experimental | Other: Follow up, Drug: chemotherapyC1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pathologically confirmed HM.
- The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
- The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
- The patients are willing to compliant with the study protocol and be followed up at regular intervals.
- The patients agree to sign an informed consent form.
Key exclusion criteria (7 listed)
- The patients with a previous history of lung nodules.
- The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
- The patients have undergone prophylactic hysterectomy or chemotherapy.
- Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
- Patients have immunosuppressive diseases or take immunosuppressants.
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 |
|---|---|---|
| Follow upAlso: not chemotherapy immediatelythe follow up group would be naturely didived into 2 subgroups depending the hCG regression degree. | Other | B:follow up, C: lung nodule diameter <1.0 cm |
| chemotherapyAlso: mtx for low riskFirst line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO | Drug | A:chemotherapy immediately, B:follow up, C: lung nodule diameter <1.0 cm |
Primary outcome
chemotherapy cycles
Time frame: 120 months
the efficacy and number of treatment cycles in the chemotherapy group
hCG declined to normal spontaneously of group B
Time frame: 120 months
the spontaneous regression rate in Group B
2 secondary outcomes
follow up of group A , B and C
Time frame: 240 months
lung nodules
Time frame: 240 months
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 16 Mar 2026.
- 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.
Xing Xie principal investigator
Women's Hospital, Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up and chemotherapy in people with Hydatidiform Mole and Gestational Trophoblastic Neoplasia, run by Women's Hospital School Of Medicine Zhejiang University 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
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?
Contact Xiao Li, dortor (008657189992206, 5198008@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chemotherapy cycles (time frame: 120 months). The study lists 2 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 16 Mar 2026.