LUCINAE Registry: Thoracic Cancers During Pregnancy (LUCINAE)
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Martina Imbimbo
- Telefonnummer: +41918119631
- E-Mail: Martina.Imbimbo@eoc.ch
Studieren Sie die Kontaktsicherung
- Name: Luigi Tortola
- Telefonnummer: +41 91 811 96 68
- E-Mail: luigi.tortola@eoc.ch
Studienorte
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Baden, Schweiz
- Rekrutierung
- Kantonsspital Baden
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Kontakt:
- Sacha Rothschild, Site Investigator
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Bellinzona, Schweiz
- Rekrutierung
- Istituto Oncologico della Svizzera Italiana (IOSI)
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Kontakt:
- Martina Imbimbo, Project Leader
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Geneva, Schweiz
- Rekrutierung
- Geneva University Hospital (HUG)
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Kontakt:
- Alfredo Addeo, Site Investigator
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Winterthur, Schweiz
- Rekrutierung
- Kantonsspital Winterthur
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Kontakt:
- Laetitia Mauri, Site Investigator
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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:
- Patients receiving a diagnosis of thoracic cancer during pregnancy
- Patients who became pregnant while having active thoracic cancer
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Cohort A
Retrospective patients: patients who are included in the registry only after death.
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Cohort B
Prospective patients: patients who are currently treated at the participating site or will be diagnosed during the enrollment
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Timing of diagnosis
Zeitfenster: At the moment of patient enrolment
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Timing of cancer diagnosis with respect to the onset of pregnancy.
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At the moment of patient enrolment
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Modality of diagnosis
Zeitfenster: At the moment of patient enrolment
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Method used for cancer diagnosis.
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At the moment of patient enrolment
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Duration of treatment
Zeitfenster: Throughout study participation, up to 5 years after delivery.
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Duration of the treatment received during the pregnancy
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Throughout study participation, up to 5 years after delivery.
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Maternal outcome
Zeitfenster: At the conclusion of pregnancy.
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Survival of the mother at the end of gestation.
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At the conclusion of pregnancy.
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Fetal outcome
Zeitfenster: At the conclusion of pregnancy.
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Survival of the fetus at the end of gestation.
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At the conclusion of pregnancy.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Parental overall survival
Zeitfenster: From thoracic cancer diagnosis until 5 years after delivery.
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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.
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From thoracic cancer diagnosis until 5 years after delivery.
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Offspring's overall survival
Zeitfenster: From birth until 5 years after birth.
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Overall survival of the offspring of enrolled parents, defined as time from birth to death from any cause.
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From birth until 5 years after birth.
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Pregnancy complications
Zeitfenster: From pregnancy diagnosis to 1 month after delivery.
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Incidence of complications associated with the pregnancy.
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From pregnancy diagnosis to 1 month after delivery.
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Gestational age at delivery
Zeitfenster: At the conclusion of pregnancy.
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Gestational age of the fetus at the moment of delivery.
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At the conclusion of pregnancy.
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Congenital abnormalities
Zeitfenster: From birth to 30 days after birth.
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Proportion of newborns diagnosed with congenital abnormalities.
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From birth to 30 days after birth.
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Neonatal intensive care unit (NICU) admission
Zeitfenster: From birth to 30 days after birth.
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Proportion of newborns admitted to neonatal intensive care unit after birth.
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From birth to 30 days after birth.
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Apgar score
Zeitfenster: Measured 1 minute and 5 minutes after birth.
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Measurement of Apgar score to assess the newborn's vital signs and immediate need for medical intervention.
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Measured 1 minute and 5 minutes after birth.
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Oncologic treatment exposure
Zeitfenster: Throughout pregnancy until 5 years after delivery.
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Type, timing, and toxicity of anticancer treatments administered during and after pregnancy.
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Throughout pregnancy until 5 years after delivery.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LUCINAE Registry
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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