An Ambispective Observational Registry Study of Pregnancy and Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 866
- 试验地点
- 28
- 主要终点
- 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
研究概览
简要总结
An ambispective observational registry study of pregnancy and breast cancer
详细描述
A multicenter, observational, non-post-marketing (non-PMS), ambispective (retrospective and prospective from the registry opening) study which will enroll patients with breast cancer in any of these three situations:
- Patients with gestational breast cancer, defined as breast cancer diagnosed during pregnancy, breastfeeding or up to a year after delivery.
- Patients who become pregnant after a breast cancer diagnosis.
- Patients with breast cancer who have followed any fertility preservation technique prior to the start of breast cancer treatment.
It is estimated a minimum recruitment period of approximately 3 years from the study activation. The study will remain open as long as possible in order to collect as much information as possible. GEICAM will actively search for funding for this.
Patients may also be concurrently enrolled in an interventional clinical trial. This observational registry study of pregnancy and breast cancer that collects significant data obtained from standard clinical practice, regarding the clinical characteristics of patients with breast cancer in any of the three situations described above. These data will allow the performance of both descriptive and exploratory analyses in order to evaluate the associations between different breast cancer subtypes and risk factors observed.
Finally, this study will collect high quality molecular data derived from the analysis of biological samples (paraffin-embedded tumor and peripheral blood samples) to reach a better understanding of the biological mechanisms involved in breast cancer in relation to pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient should have signed and dated the informed consent form (ICF). The enrollment of patients who have died is allowed.
- •Women aged ≥ 18 years.
- •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.
- •The patients referred to in the previous section and the patients who meet these characteristics prospectively could be enrolled retrospectively upon registry opening.
- •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.
- •Availability of clinical, epidemiological and progress data.
排除标准
- •Patients who do not wish to participate in the study for any reason could not be included in the study.
结局指标
主要结局
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
时间窗: Baseline visit
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.
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
时间窗: Baseline visit
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.
Age 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
时间窗: Baseline visit
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.
次要结局
- Clinicopathological characteristics of cancer: metastasis presence(3 years)
- Clinicopathological characteristics of cancer: BRCA1 and 2 mutations(3 years)
- Association between gestational breast cancer and a specific genotype or gene expression profile.(3 years)
- Progress of the babies born from women diagnosed with gestational breast cancer or women with breast cancer diagnosis who became pregnant.(3 years)
- Clinicopathological characteristics of cancer: lymph node condition(3 years)
- Clinicopathological characteristics of cancer: hormonal receptor status(3 years)
- Clinicopathological characteristics of cancer: human epidermal growth factor receptor 2 (HER2) condition(3 years)
- Clinicopathological characteristics of cancer: Tumor size(3 years)
- Pregnancy outcome from women diagnosed with gestational breast cancer or women with breast cancer diagnosis who became pregnant.(3 years)
- Clinicopathological characteristics of cancer: histopathological differentiation degree(3 years)
- Progression-free survival (PFS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.(3 years)
- Overall survival (OS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.(3 years)
- Number of patients with breast cancer managed to get pregnant, spontaneously or through in vitro fertilization (IVF) methods(3 years)
- Clinicopathological characteristics of cancer: Ki67 proliferation index(3 years)
- Disease-free survival (DFS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.(3 years)
- Correlation of the molecular profiles identified with the patients' clinicopathological and epidemiological characteristics and their disease evolution.(3 years)
- Enumerate the potential risks of fertility preservation techniques in women with breast cancer.(3 years)
- Event-free survival (EFS) of pregnant women with breast cancer, pregnant patients after breast cancer and patients who have undergone techniques for the preservation of fertility.(3 years)
- Number of patients with breast cancer that have followed fertility preservation techniques and what type of techniques were used.(3 years)