Clinical trial NCT03785574: Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule
Official title: Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hydatidiform Mole
Gestational Trophoblastic Neoplasia
Keywords: Pulmonary Nodule
Chemotherapy
Chorionic Gonadotrophin
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Tongji Hospital Affiliated to Tongji Medical College of HUST
name: The First People's Hospital of Yunnan
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Women and Children's Hospital of Ningbo University
name: First Affiliated Hospital of Wenzhou Medical University
name: Hangzhou Fuyang Women And Children Hospital
name: Zhejiang Provincial Tongde Hospital
name: Shaoxing Shangyu Women And Children Hospital
name: Huzhou Maternity and Child Health Care Hospital
First posted: 2018-12-24
Enrollment: 30
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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)

Eligibility criteria: Inclusion criteria

Eligible patients have to meet all of the following criteria:

1. Pathologically confirmed HM.
2. The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
3. The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
4. The patients are willing to compliant with the study protocol and be followed up at regular intervals.
5. The patients agree to sign an informed consent form.

Exclusion criteria

1. The patients with a previous history of lung nodules.
2. The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
3. The patients have undergone prophylactic hysterectomy or chemotherapy.
4. Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
5. Patients have immunosuppressive diseases or take immunosuppressants.
6. Patients are participating in other clinical trials at same time.
7. Patients were unable or unwilling to provide written informed consent.

Primary outcomes:
measure: chemotherapy cycles
timeFrame: 120 months
measure: hCG declined to normal spontaneously of group B
timeFrame: 120 months
Secondary outcomes:
measure: follow up of group A , B and C
timeFrame: 240 months
measure: lung nodules
timeFrame: 240 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Weiguo Lv
state: Zhejiang
Study officials:
affiliation: Women's Hospital, Zhejiang University School of Medicine
name: Xing Xie
role: PRINCIPAL_INVESTIGATOR
References: