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LUCINAE Registry: Thoracic Cancers During Pregnancy (LUCINAE)

7. juli 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sveits
      • Baden, Sveits
        • Rekruttering
        • Kantonsspital Baden
        • Ta kontakt med:
          • Sacha Rothschild, Site Investigator
      • Bellinzona, Sveits
        • Rekruttering
        • Istituto Oncologico della Svizzera Italiana (IOSI)
        • Ta kontakt med:
          • Martina Imbimbo, Project Leader
      • Geneva, Sveits
        • Rekruttering
        • Geneva University Hospital (HUG)
        • Ta kontakt med:
          • Alfredo Addeo, Site Investigator
      • Winterthur, Sveits
        • Rekruttering
        • Kantonsspital Winterthur
        • Ta kontakt med:
          • Laetitia Mauri, Site Investigator

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parental overall survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At the conclusion of pregnancy.
Gestational age of the fetus at the moment of delivery.
At the conclusion of pregnancy.
Congenital abnormalities
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Oncology Institute of Southern Switzerland

Samarbeidspartnere

Clinical Trial Unit Ente Ospedaliero Cantonale

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2035

Studiet fullført (Antatt)

1. desember 2035

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LUCINAE Registry

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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