LUCINAE: LUng and Thoracic Cancers In pregNAncy rEgistry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Timing of diagnosis
研究概览
简要总结
The LUCINAE Registry is an international, multicenter observational study collecting data on patients with thoracic cancers (including lung cancer) who are expecting a child. This includes women diagnosed during pregnancy, women who become pregnant during or after cancer, and men receiving cancer treatment at the time their partner conceives.
Because thoracic cancers during pregnancy are rare, there is limited information to guide clinical decisions. This registry aims to describe patient characteristics, diagnostic approaches, treatments, and maternal and fetal outcomes. Data are collected retrospectively and prospectively from participating centers.
The results of this registry are expected to improve understanding of thoracic cancers in this setting and support the development of future clinical recommendations.
详细描述
The LUCINAE Registry (LUng and thoracic Cancers In pregNAncy rEgistry) is an international, multicenter registry with retrospective and prospective (ambispective) data collection.
The incidence of cancers in younger individuals is increasing, and due to delayed maternal age and other factors, more patients are diagnosed with cancer during pregnancy or become pregnant during or after cancer treatment. Thoracic cancers during pregnancy are rare events, but they are associated with high maternal morbidity and mortality and may have important implications for fetal outcomes.
Currently, there is a lack of specific clinical guidelines for the management of thoracic cancers during pregnancy, and limited data are available regarding the safety and outcomes of anticancer treatments in this setting. Existing registries are not specific for thoracic malignancies, and available evidence is based on a limited number of reported cases.
The LUCINAE Registry aims to collect comprehensive data on biologically female and male patients with thoracic cancers who are expecting a child. The primary objective is to describe clinical and biological characteristics, family history, treatments, and maternal and fetal outcomes.
The study includes two cohorts:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. All patients with a diagnosis of thoracic cancer (including lung cancer, mesothelioma, thymic epithelial tumors, neuroendocrine tumors or sarcoma of the thorax and other rare thoracic entities) and pregnancy (positive pregnancy test) including:
- •Patients receiving a diagnosis of thoracic cancer during pregnancy
- •Patients who became pregnant while having active thoracic cancer
- •Patients previously treated for a thoracic cancer and becoming pregnant in the 5 years following end of treatment OR Men with a diagnosis of thoracic cancer (including lung cancer, mesothelioma, thymic epithelial tumors, neuroendocrine tumors or sarcoma of the thorax and other rare thoracic entities), who were undergoing active oncological treatment at the time their partner conceived their child.
- •2. Available information about pregnancy outcomes
- •3. Age ≥ 18 years
排除标准
- •1. Patient missing data about thoracic cancer stage and diagnosis
- •2. For retrospective patients, documented refusal to the use of clinical data for research purposes
研究组 & 干预措施
Cohort A
Retrospective patients: patients who are included in the registry only after death.
Cohort B
Prospective patients: patients who are currently treated at the participating site or will be diagnosed during the enrollment
结局指标
主要结局
Timing of diagnosis
时间窗: At the moment of patient enrolment
Timing of cancer diagnosis with respect to the onset of pregnancy.
Modality of diagnosis
时间窗: At the moment of patient enrolment
Method used for cancer diagnosis.
Maternal outcome
时间窗: At the conclusion of pregnancy.
Survival of the mother at the end of gestation.
Fetal outcome
时间窗: At the conclusion of pregnancy.
Survival of the fetus at the end of gestation.
Duration of treatment
时间窗: Throughout study participation, up to 5 years after delivery.
Duration of the treatment received during the pregnancy
次要结局
- Parental overall survival(From thoracic cancer diagnosis until 5 years after delivery.)
- Offspring's overall survival(From birth until 5 years after birth.)
- Pregnancy complications(From pregnancy diagnosis to 1 month after delivery.)
- Gestational age at delivery(At the conclusion of pregnancy.)
- Congenital abnormalities(From birth to 30 days after birth.)
- Neonatal intensive care unit (NICU) admission(From birth to 30 days after birth.)
- Apgar score(Measured 1 minute and 5 minutes after birth.)
- Oncologic treatment exposure(Throughout pregnancy until 5 years after delivery.)