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LUCINAE Registry: Thoracic Cancers During Pregnancy (LUCINAE)

7 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Timing of diagnosis
Tidsram: 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
Tidsram: At the moment of patient enrolment
Method used for cancer diagnosis.
At the moment of patient enrolment
Duration of treatment
Tidsram: 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
Tidsram: At the conclusion of pregnancy.
Survival of the mother at the end of gestation.
At the conclusion of pregnancy.
Fetal outcome
Tidsram: At the conclusion of pregnancy.
Survival of the fetus at the end of gestation.
At the conclusion of pregnancy.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Parental overall survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At the conclusion of pregnancy.
Gestational age of the fetus at the moment of delivery.
At the conclusion of pregnancy.
Congenital abnormalities
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Oncology Institute of Southern Switzerland

Samarbetspartners

Clinical Trial Unit Ente Ospedaliero Cantonale

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 december 2035

Avslutad studie (Beräknad)

1 december 2035

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

13 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LUCINAE Registry

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