Cancer During Pregnancy, Lung Cancer, Thoracic Cancer
Conditions
Keywords
thoracic cancers during pregnancy, Lung cancer during pregnancy
Brief summary
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.
Interventions
None listed
Sponsors
Oncology Institute of Southern Switzerland
Clinical Trial Unit Ente Ospedaliero Cantonale
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timing of diagnosis | At the moment of patient enrolment | Timing of cancer diagnosis with respect to the onset of pregnancy. |
| Modality of diagnosis | At the moment of patient enrolment | Method used for cancer diagnosis. |
| Duration of treatment | Throughout study participation, up to 5 years after delivery. | Duration of the treatment received during the pregnancy |
| Maternal outcome | At the conclusion of pregnancy. | Survival of the mother at the end of gestation. |
| Fetal outcome | At the conclusion of pregnancy. | Survival of the fetus at the end of gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental overall survival | 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. |
| Offspring's overall survival | 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. |
| Pregnancy complications | From pregnancy diagnosis to 1 month after delivery. | Incidence of complications associated with the pregnancy. |
| Gestational age at delivery | At the conclusion of pregnancy. | Gestational age of the fetus at the moment of delivery. |
| Congenital abnormalities | From birth to 30 days after birth. | Proportion of newborns diagnosed with congenital abnormalities. |
| Neonatal intensive care unit (NICU) admission | From birth to 30 days after birth. | Proportion of newborns admitted to neonatal intensive care unit after birth. |
| Apgar score | 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. |
| Oncologic treatment exposure | Throughout pregnancy until 5 years after delivery. | Type, timing, and toxicity of anticancer treatments administered during and after pregnancy. |
Countries
Switzerland
Contacts
CONTACTMartina Imbimbo
CONTACTLuigi Tortola
Outcome results
None listed