Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,050
- 试验地点
- 7
- 主要终点
- Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
研究概览
简要总结
SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer, advanced stage treatment-naïve cervical or vulva cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.
详细描述
Patients will have blood and +/- tumor samples at the following times :
- if eligible for surgery :
- at surgery (blood + tumor and nodes)
- after surgery (blood)
- 6 months after surgery if non recurrence (Blood)
- before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes if possible)
- before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
- at progression (blood + tumor biopsie and nodes if possible)
- if eligible for neoadjuvant chemotherapy :
- before neoadjuvant therapy (blood + tumor biopsie and nodes)
- during neoadjuvant therapy (post cycle 1) (blood)
- at the time of surgery (blood + tumor and nodes)
- 6 months after surgery if non recurrence (Blood)
- before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes)
- before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
- at progression (blood + tumor biopsie and nodes)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Tumor types :
- •Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy
- •Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy
- •Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery
- •Newly diagnosed treatment-naïve vulva cancer (all types) or cervical cancer patients with (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).
- •Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment
- •Male or female patients ≥ 18 years of age
- •Signed informed consent
排除标准
- •Male or female patients ≤18 years old
- •Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Individually deprived of liberty or placed under the authority of a tutor
- •Patients not affiliated to the Social Security System
研究组 & 干预措施
Tumor and blood sampling
Patients will have a biopsy or a surgery and blood sampling at different time points.
干预措施: Tumor biopsies / Tumor surgery (Procedure)
Tumor and blood sampling
Patients will have a biopsy or a surgery and blood sampling at different time points.
干预措施: Blood withdrawal (Procedure)
结局指标
主要结局
Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
时间窗: up to 6 months
次要结局
- Correlation between ctDNA levels, de novo mutations in ctDNA and immune(up to 24 months)
- Correlation between disease recurrence and molecular and/or immunological biomarkers(up to 24 months)
- Correlation between genomic alterations and immune parameters(up to 24 months)
- Correlation between mutations load and immune parameters(up to 24 months)
- For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence(up to 24 months)