Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- MicroRNA profile
研究概览
简要总结
The goal of this observational pilot study is to explore whether we can identify biomarkers predictive for the diagnosis of adrenocortical carcinoma in blood. Five participants who are suspected to have adrenocortical carcinoma will undergo an adrenal vein sampling in order to obtain a blood sample from the adrenal vein. This blood sample will be analyzed and compared to blood samples taken from the adrenal vein of 20 control patients, which are patients who do not have adrenocortical carcinoma. The blood samples of the control patients will be drawn during routine medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •In order to be eligible to participate in the study group, a subject must meet all of the following criteria:
- •Patient age ≥18 years
- •High clinical suspicion of adrenocortical carcinoma, based on clinical signs (due to hormonal overproduction), steroid hormone profile and radiological features (e.g. tumor size ≥4cm, inhomogenous aspect and tumor attenuation of HU ≥10)
- •Able to provide signed informed consent
- •In order to be eligible to participate in the control group, a subject must meet all of the following criteria:
- •Patient age ≥18 years
- •Routine diagnostic process includes AVS
- •No suspicion of malignancy
- •Able to provide signed informed consent
排除标准
- •Patients are not able to participate if:
- •They have a known allergy to (iodinated) contrast fluid
- •They use vitamin K antagonizing anticoagulants or DOAC's, except for when on the day of the adrenal vein sampling the anticoagulants are already stopped for the following adrenal surgery, and in case of using vitamin K antagonizing anticoagulants the INR is <3
- •The platelet count is below 20
- •Anatomy of the adrenal vein is not suitable for performing the AVS procedure, based on the judgement of an experienced interventional radiologist
- •Contraindications for use of Synacthen
- •They have a known hypersensitivity to any of the substances of Synacthen
- •They are pregnant
结局指标
主要结局
MicroRNA profile
时间窗: Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed.
miRNAs with a log2Fold change \> \|1\| difference in expression in patient compared to control samples.
Presence of mutations in ctDNA
时间窗: Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed
Presence of mutations will be assessed in patient samples and compared to control samples
ctDNA methylation pattern
时间窗: Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed
Differentially methylated probes and differentially methylated regions will be assessed as those with a beta \>0.8 and \<0.2
Steroid profile
时间窗: Analyses will be done at the end of inclusion of all patients, this will be after 2 years. Blood drawn before surgery/treatment will be analysed
Laboratory values will be compared using Mann-Whitney-U tests
次要结局
未报告次要终点
研究者
Richard Feelders
Principal Investigator
Erasmus Medical Center