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LUCINAE Registry: Thoracic Cancers During Pregnancy (LUCINAE)

7 июля 2026 г. обновлено: Oncology Institute of Southern Switzerland

LUCINAE: LUng and Thoracic Cancers In pregNAncy rEgistry

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.

Обзор исследования

Статус

Рекрутинг

Условия

Подробное описание

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:

Cohort A (retrospective): patients included after death, with data collected from medical records.

Cohort B (prospective): patients currently treated or diagnosed during the enrollment period, with longitudinal follow-up and periodic data updates.

Eligible participants include women diagnosed with thoracic cancer during pregnancy, women who become pregnant during active disease or within 5 years after treatment, and men receiving active oncological treatment at the time their partner conceives.

Data collected include patient characteristics (demographics, medical history, genetic information), tumor characteristics (stage, histology, biomarker status), diagnostic procedures, treatment details (including systemic therapies, surgery, and radiotherapy), pregnancy characteristics, complications, and maternal and fetal outcomes. Follow-up data are collected at multiple timepoints up to 5 years after delivery, when available.

Analyses will be primarily descriptive and will evaluate clinical and biological characteristics, treatment patterns, and outcomes. Correlation analyses between treatments and outcomes will also be performed. The study does not impose any intervention, and all treatment decisions are made by the treating physicians.

The registry is intended to improve understanding of thoracic cancers in the context of pregnancy, to support future research, and to contribute to the development of clinical management strategies for this patient population.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

100

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Martina Imbimbo
Номер телефона: +41918119631
Электронная почта: Martina.Imbimbo@eoc.ch

Учебное резервное копирование контактов

Имя: Luigi Tortola
Номер телефона: +41 91 811 96 68
Электронная почта: luigi.tortola@eoc.ch

Места учебы

Швейцария
- - Baden, Швейцария
    - Рекрутинг
    - Kantonsspital Baden
    - Контакт:
      
      Sacha Rothschild, Site Investigator
  - Bellinzona, Швейцария
    - Рекрутинг
    - Istituto Oncologico della Svizzera Italiana (IOSI)
    - Контакт:
      
      Martina Imbimbo, Project Leader
  - Geneva, Швейцария
    - Рекрутинг
    - Geneva University Hospital (HUG)
    - Контакт:
      
      Alfredo Addeo, Site Investigator
  - Winterthur, Швейцария
    - Рекрутинг
    - Kantonsspital Winterthur
    - Контакт:
      
      Laetitia Mauri, Site Investigator

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

The study will include all pregnant biological female patients, of any ethnicity, with a diagnosis of thoracic cancer at any stage and men with a diagnosis of thoracic cancer who were undergoing active oncological treatment at the time their partner conceived their child.

Описание

Inclusion Criteria:

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:
1. Patients receiving a diagnosis of thoracic cancer during pregnancy
2. Patients who became pregnant while having active thoracic cancer
3. 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

Exclusion Criteria:

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
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

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Timing of diagnosis Временное ограничение: At the moment of patient enrolment	Timing of cancer diagnosis with respect to the onset of pregnancy.	At the moment of patient enrolment
Modality of diagnosis Временное ограничение: At the moment of patient enrolment	Method used for cancer diagnosis.	At the moment of patient enrolment
Duration of treatment Временное ограничение: Throughout study participation, up to 5 years after delivery.	Duration of the treatment received during the pregnancy	Throughout study participation, up to 5 years after delivery.
Maternal outcome Временное ограничение: At the conclusion of pregnancy.	Survival of the mother at the end of gestation.	At the conclusion of pregnancy.
Fetal outcome Временное ограничение: At the conclusion of pregnancy.	Survival of the fetus at the end of gestation.	At the conclusion of pregnancy.

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Parental overall survival Временное ограничение: From thoracic cancer diagnosis until 5 years after delivery.	Overall survival of biologically female and male thoracic cancer patients included in the registry, defined as time from thoracic cancer diagnosis to death from any cause.	From thoracic cancer diagnosis until 5 years after delivery.
Offspring's overall survival Временное ограничение: From birth until 5 years after birth.	Overall survival of the offspring of enrolled parents, defined as time from birth to death from any cause.	From birth until 5 years after birth.
Pregnancy complications Временное ограничение: From pregnancy diagnosis to 1 month after delivery.	Incidence of complications associated with the pregnancy.	From pregnancy diagnosis to 1 month after delivery.
Gestational age at delivery Временное ограничение: At the conclusion of pregnancy.	Gestational age of the fetus at the moment of delivery.	At the conclusion of pregnancy.
Congenital abnormalities Временное ограничение: From birth to 30 days after birth.	Proportion of newborns diagnosed with congenital abnormalities.	From birth to 30 days after birth.
Neonatal intensive care unit (NICU) admission Временное ограничение: From birth to 30 days after birth.	Proportion of newborns admitted to neonatal intensive care unit after birth.	From birth to 30 days after birth.
Apgar score Временное ограничение: Measured 1 minute and 5 minutes after birth.	Measurement of Apgar score to assess the newborn's vital signs and immediate need for medical intervention.	Measured 1 minute and 5 minutes after birth.
Oncologic treatment exposure Временное ограничение: Throughout pregnancy until 5 years after delivery.	Type, timing, and toxicity of anticancer treatments administered during and after pregnancy.	Throughout pregnancy until 5 years after delivery.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Oncology Institute of Southern Switzerland

Соавторы

Clinical Trial Unit Ente Ospedaliero Cantonale

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июня 2026 г.

Первичное завершение (Оцененный)

1 декабря 2035 г.

Завершение исследования (Оцененный)

1 декабря 2035 г.

Даты регистрации исследования

Первый отправленный

11 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

7 июля 2026 г.

Первый опубликованный (Действительный)

13 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)