NCT04920955已完成不适用
Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse
Novigenix SA1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2021年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Sensitivity for relapse detection
研究概览
简要总结
This is an observational case-control study which enroll metastatic and non-metastatic colorectal cancer (CRC) patients. The objective of this study is to evaluate a novel blood multi-marker test for the detection of relapse in colorectal cancer patients. This test is based on whole-blood transcriptomic signatures and circulating tumor methylated DNA markers. The patients will be enrolled into 4 study groups, two cross-sectional and two longitudinal groups, to follow up patients up to 36 months from primary tumor resection.
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
- •Male or female ≥ 18 years of age at time of informed consent.
- •Subject has signed the informed consent form (ICF) and is able to understand the information provided in it.
- •At least a blood sample is collected per subject according to the sample collection protocol.
- •Patients enrolled in local prospective protocols, in which samples have been collected according the study procedures may be included.
- •Group 1: patients with a radiologically and, whenever is possible, histologically confirmed relapse (local or distant) of colorectal cancer within 5 years from primary surgery. Metachronous primary tumors are not considered as relapse and should be excluded.
- •Group 2: Patients declared disease-free for at least 36 months but less than 5 years, as confirmed by radiological examination.
- •Group 3: Patients with a stage III-IV colorectal cancer with a curative treatment and disease-free for at least 3 months but less than 18 months.
- •Group 4: Histologically and radiologically confirmed diagnosis of stage I, II, III or IV colorectal adenocarcinoma, eligible for a treatment with curative intent.
排除标准
- •Personal history of cancer (non-hematologic) other than CRC in complete remission for less than 5 years.
- •Personal history of hematologic cancer.
- •A blood transfusion within 6 weeks prior to inclusion into the study.
- •Transplant with regular intake of immunosuppressants.
- •Pregnant woman (self-declaration).
- •Conditions or comorbidities that would preclude the compliance with the planned surveillance program or with the protocol as judged by the Investigator.
- •Previous inclusion in the RELMA-C study and/or re-inclusion in a different study group.
- •Group 1: Any treatment for CRC relapse prior to blood collection.
- •Group 2: Patient is disease-free for less than 36 months or more than 5 years.
- •Group 3: Patient is disease-free for less than 3 months or more than 18 months
- •Group 3: Stage IV patients with detectable residual disease after primary treatment.
- •Group 4: Any cancer treatment prior to blood collection.
结局指标
主要结局
Sensitivity for relapse detection
时间窗: Relapse occurring within 5 years from primary curative intervention
Sensitivity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method
Specificity for relapse detection
时间窗: 36 months disease-free
Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method
次要结局
- Coefficient of variation of the biomarkers(6 weeks)
- Concordance analyses(24 months)
- Test positivity(24 months)
- Sensitivity for CRC detection(up to 1 day prior to tumor resection)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy CompletionColorectal CancerNCT03598166Peter S. Liang, MD MPH359
已完成
不适用
Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening ProtocolColorectal CancerNCT01196130M.D. Anderson Cancer Center1,275
已完成
不适用
Non-invasive Identification of Colorectal Cancer and Adenomas in Early StagesColorectal CancerNCT05445570Venn Biosciences Corporation3,002
已完成
不适用
Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal CancersStage III Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8NCT03563651University of Southern California29
招募中
不适用
Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)Cirrhosis, LiverNAFLDHBVHCVHCCNCT05781568Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis60