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LUCINAE Registry: Thoracic Cancers During Pregnancy (LUCINAE)

7 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Suisse
      • Baden, Suisse
        • Recrutement
        • Kantonsspital Baden
        • Contact:
          • Sacha Rothschild, Site Investigator
      • Bellinzona, Suisse
        • Recrutement
        • Istituto Oncologico della Svizzera Italiana (IOSI)
        • Contact:
          • Martina Imbimbo, Project Leader
      • Geneva, Suisse
        • Recrutement
        • Geneva University Hospital (HUG)
        • Contact:
          • Alfredo Addeo, Site Investigator
      • Winterthur, Suisse
        • Recrutement
        • Kantonsspital Winterthur
        • Contact:
          • Laetitia Mauri, Site Investigator

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Timing of diagnosis
Délai: 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
Délai: At the moment of patient enrolment
Method used for cancer diagnosis.
At the moment of patient enrolment
Duration of treatment
Délai: 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
Délai: At the conclusion of pregnancy.
Survival of the mother at the end of gestation.
At the conclusion of pregnancy.
Fetal outcome
Délai: At the conclusion of pregnancy.
Survival of the fetus at the end of gestation.
At the conclusion of pregnancy.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Parental overall survival
Délai: 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
Délai: 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
Délai: 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
Délai: At the conclusion of pregnancy.
Gestational age of the fetus at the moment of delivery.
At the conclusion of pregnancy.
Congenital abnormalities
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Oncology Institute of Southern Switzerland

Collaborateurs

Clinical Trial Unit Ente Ospedaliero Cantonale

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 décembre 2035

Achèvement de l'étude (Estimé)

1 décembre 2035

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

13 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LUCINAE Registry

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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