LUCINAE Registry: Thoracic Cancers During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Thoracic Cancer, Cancer During Pregnancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
LUCINAE: LUng and Thoracic Cancers In pregNAncy rEgistry
Overview
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.
Detailed description
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.
Primary outcome measures
- Timing of diagnosis [Time frame: At the moment of patient enrolment]
- Modality of diagnosis [Time frame: At the moment of patient enrolment]
- Duration of treatment [Time frame: Throughout study participation, up to 5 years after delivery.]
- Maternal outcome [Time frame: At the conclusion of pregnancy.]
- Fetal outcome [Time frame: At the conclusion of pregnancy.]
Secondary outcome measures (8)
- Parental overall survival [Time frame: From thoracic cancer diagnosis until 5 years after delivery.]
- Offspring's overall survival [Time frame: From birth until 5 years after birth.]
- Pregnancy complications [Time frame: From pregnancy diagnosis to 1 month after delivery.]
- Gestational age at delivery [Time frame: At the conclusion of pregnancy.]
- Congenital abnormalities [Time frame: From birth to 30 days after birth.]
- Neonatal intensive care unit (NICU) admission [Time frame: From birth to 30 days after birth.]
- Apgar score [Time frame: Measured 1 minute and 5 minutes after birth.]
- Oncologic treatment exposure [Time frame: Throughout pregnancy until 5 years after delivery.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 4 centers
- Kantonsspital Baden — Baden
- Istituto Oncologico della Svizzera Italiana (IOSI) — Bellinzona
- Geneva University Hospital (HUG) — Geneva
- Kantonsspital Winterthur — Winterthur
Identifiers
NCT: NCT07699861 · LUCINAE Registry