Clinical trial · Observational
Registry Study of Pregnancy and Breast Cancer
An Ambispective Observational Registry Study of Pregnancy and Breast Cancer
NCT04603820CI-TRIAL-00099243EMBARCAMactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An ambispective observational registry study of pregnancy and breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer and Pregnancy | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment
- timeFrame
- Baseline visit
- description
- Data for this study will be recorded into the electronic case report form (eCRF) via web using Remote Data Capture (RDC) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned. Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.
- measure
- Race of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment
- timeFrame
- Baseline visit
- description
- Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned. Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient should have signed and dated the informed consent form (ICF). The enrollment of patients who have died is allowed. 2. Women aged ≥ 18 years. 3. Patients in one of the following situations: * Patients with breast cancer diagnosis during pregnancy, breastfeeding or within the year after delivery. * Patients with breast cancer who become pregnant after treatment. * Patients with breast cancer who were subjected to any fertility preservation method prior to the start of breast cancer treatment. 4. The patients referred to in the previous section and the patients who meet these characteristics prospectively could be enrolled retrospectively upon registry opening. 5. All cases diagnosed at the same site may be included. In order to prevent duplications, in case the patient followed her treatment and follow-up at another site, she will be enrolled as per the site where the diagnosis was made, requesting information of the treatment and progression, when possible. 6. Availability of clinical, epidemiological and progress data. Exclusion Criteria: Patients who do not wish to participate in the study for any reason could not be included in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.