Lung CancerLUCINAENCT07699861
LUCINAE Registry: Thoracic Cancers During Pregnancy
An observational study of Lung Cancer and Thoracic Cancer, run by Oncology Institute of Southern Switzerland at 4 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Thoracic Cancer, Cancer During Pregnancy
- How many people
- 100 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 23 Apr 2026to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Kantonsspital Baden
Baden
Sacha Rothschild, Site Investigator
- Recruiting
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona
Martina Imbimbo, Project Leader
- Recruiting
Geneva University Hospital (HUG)
Geneva
Alfredo Addeo, Site Investigator
- Recruiting
Kantonsspital Winterthur
Winterthur
Laetitia Mauri, Site Investigator
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Thoracic Cancer, Cancer During Pregnancy
- Keywords
- thoracic cancers during pregnancy, Lung cancer during pregnancy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of diagnosis
Timing of cancer diagnosis with respect to the onset of pregnancy.
Measured: At the moment of patient enrolment
Modality of diagnosis
Method used for cancer diagnosis.
Measured: At the moment of patient enrolment
Duration of treatment
Duration of the treatment received during the pregnancy
Measured: Throughout study participation, up to 5 years after delivery.
Maternal outcome
Survival of the mother at the end of gestation.
Measured: At the conclusion of pregnancy.
Fetal outcome
Survival of the fetus at the end of gestation.
Measured: At the conclusion of pregnancy.
Secondary outcomes (8)
Parental overall survival
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.
Measured: From thoracic cancer diagnosis until 5 years after delivery.
Offspring's overall survival
Overall survival of the offspring of enrolled parents, defined as time from birth to death from any cause.
Measured: From birth until 5 years after birth.
Pregnancy complications
Incidence of complications associated with the pregnancy.
Measured: From pregnancy diagnosis to 1 month after delivery.
Gestational age at delivery
Gestational age of the fetus at the moment of delivery.
Measured: At the conclusion of pregnancy.
Congenital abnormalities
Proportion of newborns diagnosed with congenital abnormalities.
Measured: From birth to 30 days after birth.
Neonatal intensive care unit (NICU) admission
Proportion of newborns admitted to neonatal intensive care unit after birth.
Measured: From birth to 30 days after birth.
Apgar score
Measurement of Apgar score to assess the newborn's vital signs and immediate need for medical intervention.
Measured: Measured 1 minute and 5 minutes after birth.
Oncologic treatment exposure
Type, timing, and toxicity of anticancer treatments administered during and after pregnancy.
Measured: Throughout pregnancy until 5 years after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start23 Apr 2026
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699861
- Sponsor's protocol ID
- LUCINAE Registry
- Acronym
- LUCINAE
- Status last verified
- Jul 2026
- First submitted
- 11 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUCINAE: LUng and Thoracic Cancers In pregNAncy rEgistry
- ClinicalTrials.gov ID
- NCT07699861
- Acronym / sponsor ID
- LUCINAE / LUCINAE Registry
- Conditions
- Lung Cancer, Thoracic Cancer, Cancer During Pregnancy
- Keywords
- thoracic cancers during pregnancy, Lung cancer during pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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:
- 2. Available information about pregnancy outcomes
- 3. Age ≥ 18 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Timing of diagnosis
Time frame: At the moment of patient enrolment
Timing of cancer diagnosis with respect to the onset of pregnancy.
Modality of diagnosis
Time frame: At the moment of patient enrolment
Method used for cancer diagnosis.
Duration of treatment
Time frame: Throughout study participation, up to 5 years after delivery.
Duration of the treatment received during the pregnancy
Maternal outcome
Time frame: At the conclusion of pregnancy.
Survival of the mother at the end of gestation.
Fetal outcome
Time frame: At the conclusion of pregnancy.
Survival of the fetus at the end of gestation.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Thoracic Cancer, run by Oncology Institute of Southern Switzerland at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Imbimbo (+41918119631, Martina.Imbimbo@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of diagnosis (time frame: At the moment of patient enrolment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.