Relapse Markers for Colorectal Cancer

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT04920955
• Lead Sponsor: Novigenix SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-10
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity for relapse detection	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	36 months disease-free	Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method

Secondary Outcome Measures

Name	Time	Method
Coefficient of variation of the biomarkers	6 weeks	Intra- and inter-individual coefficient of variation of the biomarkers, pre- and post-surgery and during surveillance up to relapse
Concordance analyses	24 months	Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points
Test positivity	24 months	Estimation of the multi-marker test positivity for all patients and time points
Sensitivity for CRC detection	up to 1 day prior to tumor resection	Sensitivity of the test for detection of primary CRC

Trial Locations

Locations (1)

Department of Gastroenterology, Digestive Oncology Unit; 🇧🇪 Leuven, Belgium