LUCINAE Registry: Thoracic Cancers During Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOncology Institute of Southern Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Cohort A
Group B: Cohort B
Trial outcomes
Primary outcomes
1
Timing of diagnosis
Timing of cancer diagnosis with respect to the onset of pregnancy.
Time frame
At the moment of patient enrolment2
Modality of diagnosis
Method used for cancer diagnosis.
Time frame
At the moment of patient enrolment3
Duration of treatment
Duration of the treatment received during the pregnancy
Time frame
Throughout study participation, up to 5 years after delivery.4
Maternal outcome
Survival of the mother at the end of gestation.
Time frame
At the conclusion of pregnancy.Secondary outcomes
1
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.
Time frame
From thoracic cancer diagnosis until 5 years after delivery.2
Offspring's overall survival
Overall survival of the offspring of enrolled parents, defined as time from birth to death from any cause.
Time frame
From birth until 5 years after birth.3
Pregnancy complications
Incidence of complications associated with the pregnancy.
Time frame
From pregnancy diagnosis to 1 month after delivery.4
Gestational age at delivery
Gestational age of the fetus at the moment of delivery.
Time frame
At the conclusion of pregnancy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oncology Institute of Southern Switzerland
Lead sponsor
Clinical Trial Unit Ente Ospedaliero Cantonale
Collaborator
Source ClinicalTrials.gov