Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule

Официальное название

Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial

Обзор

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

Подробное описание

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)

Вмешательства

• Другое Follow up
  the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
• Препарат chemotherapy
  First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO

Первичные конечные точки

• chemotherapy cycles [Срок оценки: 120 months]
• hCG declined to normal spontaneously of group B [Срок оценки: 120 months]

Вторичные конечные точки (2)

• follow up of group A , B and C [Срок оценки: 240 months]
• lung nodules [Срок оценки: 240 months]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Weiguo Lv — Ханчжоу

Идентификаторы

NCT: NCT03785574 · CSEM 012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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