Prospective Collection of Clinical Data and Human Body Material (HBM): Blood (Serum, Plasma, DNA) and Tissue of Cutaneous Melanoma, Non Melanoma Patients and Healthy Controls. Biobank Huidkanker
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,500
- 试验地点
- 1
- 主要终点
- Establishment of a biobank of human body material (HBM) and clinical data
研究概览
简要总结
The goal of this clinical trial is to set up a prospective, fit-for-purpose collection of human body material (HBM)-blood (serum, plasma, DNA) and tissue-and standardized clinical data of patients with cutaneous melanoma, non-melanoma skin cancer and healthy controls.
The main questions it aims to answer are:
- To create a biobank with samples of human body material (HBM): blood (serum/plasma/DNA) and tissue and clinical data of patients with cutaneous melanoma, non-melanoma and helathy controls.
- To support future research questions (after specific approval of the Ethics Committee) by using the biobank (through satellite protocols).
If there is a comparison group: Not applicable (umbrella protocol for collection only).
Participants will:
-
Share demographics, medical and surgical history, risk factors.
-
Complete Cancer Worry Scale questionnaire.
-
Provide biological samples:
-
Blood samples (serum, plasma, DNA).
-
Tissue samples (residual tissue or additional biopsy if consented).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Adult subjects (>18 years of age) at time of enrolment.
- •Subjects diagnosed with cutaneous melanoma, Non-melanoma skin cancer or healthy controls.
- •Adult subjects able and willing to provide informed consent.
排除标准
- •Subjects unable or not willing to provide informed consent.
- •Pregnancy (or willing to become pregnant) is NOT an exclusion criteria (unless specified in the respective satellite protocols.
研究组 & 干预措施
Biobank Collection Arm
Participants diagnosed with cutaneous melanoma or non-melanoma skin cancer or healthy controls will provide informed consent for collection and long-term storage of human body material (HBM)-blood (serum, plasma, DNA) and tissue-and associated clinical data for future research.
干预措施: Collection of Human Body Material and Clinical Data (Other)
结局指标
主要结局
Establishment of a biobank of human body material (HBM) and clinical data
时间窗: Baseline (diagnosis and informed consent) through study completion, approximately 10 years.
Successful prospective collection and long-term storage of blood (serum, plasma, DNA), tissue samples, and associated clinical data from patients with cutaneous melanoma, non-melanoma skin cancer and healthy controls.
次要结局
- Availability of biobank resources for future research(Baseline (diagnosis and informed consent) through study completion, approximately 10 years.)