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LUCINAE Registry: Thoracic Cancers During Pregnancy (LUCINAE)

2026年7月7日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • スイス
      • Baden、スイス
        • 募集
        • Kantonsspital Baden
        • コンタクト：
          • Sacha Rothschild, Site Investigator
      • Bellinzona、スイス
        • 募集
        • Istituto Oncologico della Svizzera Italiana (IOSI)
        • コンタクト：
          • Martina Imbimbo, Project Leader
      • Geneva、スイス
        • 募集
        • Geneva University Hospital (HUG)
        • コンタクト：
          • Alfredo Addeo, Site Investigator
      • Winterthur、スイス
        • 募集
        • Kantonsspital Winterthur
        • コンタクト：
          • Laetitia Mauri, Site Investigator

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Timing of diagnosis
時間枠：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
時間枠：At the moment of patient enrolment
Method used for cancer diagnosis.
At the moment of patient enrolment
Duration of treatment
時間枠：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
時間枠：At the conclusion of pregnancy.
Survival of the mother at the end of gestation.
At the conclusion of pregnancy.
Fetal outcome
時間枠：At the conclusion of pregnancy.
Survival of the fetus at the end of gestation.
At the conclusion of pregnancy.

二次結果の測定

結果測定
メジャーの説明
時間枠
Parental overall survival
時間枠：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
時間枠：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
時間枠：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
時間枠：At the conclusion of pregnancy.
Gestational age of the fetus at the moment of delivery.
At the conclusion of pregnancy.
Congenital abnormalities
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Oncology Institute of Southern Switzerland

協力者

Clinical Trial Unit Ente Ospedaliero Cantonale

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2035年12月1日

研究の完了 (推定)

2035年12月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年7月7日

最初の投稿 (実際)

2026年7月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月7日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • LUCINAE Registry

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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