Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Qilu Hospital of Shandong University | OTHER |
| Tongji Hospital Affiliated to Tongji Medical College of HUST | UNKNOWN |
| The First People's Hospital of Yunnan | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A:chemotherapy immediately | Active Comparator | Treated with chemotherapy immediately. First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow up | Other | the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree. |
|
| Measure | Description | Time Frame |
|---|---|---|
| chemotherapy cycles | the efficacy and number of treatment cycles in the chemotherapy group | 120 months |
| hCG declined to normal spontaneously of group B | the spontaneous regression rate in Group B | 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 240 months |
| lung nodules |
Not provided
Inclusion criteria
Eligible patients have to meet all of the following criteria:
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Li, dortor | Contact | 008657189992206 | 5198008@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xing Xie | Women's Hospital, Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weiguo Lv | Recruiting | Hangzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006828 | Hydatidiform Mole |
| D031901 | Gestational Trophoblastic Disease |
| ID | Term |
|---|---|
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 |
Not provided
Not provided
| Tianjin Central Hospital of Gynecology Obstetrics |
| OTHER |
| Women and Children's Hospital of Ningbo University | UNKNOWN |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Hangzhou Fuyang Women And Children Hospital | UNKNOWN |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Shaoxing Shangyu Women And Children Hospital | UNKNOWN |
| Huzhou Maternity and Child Health Care Hospital | UNKNOWN |
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.
Not provided
Not provided
Not provided
Not provided
|
| chemotherapy | Drug | First line treatments:low risk:Methotrexate or ACTD; high risk:EMA-CO |
|
|
the changes of lung nodules
| 240 months |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |