Relapse Markers for Colorectal Cancer

Colorectal Cancer Clinical Trial

— RELMA-C  

Official title:

Evaluation of a Novel Blood Multi-marker Test for the Detection of Colorectal Cancer Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920955
• Other study ID #: S64663
• Status: Completed
• Start date: February 10, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: Novigenix SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Belgium	Department of Gastroenterology, Digestive Oncology Unit	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Novigenix SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for relapse detection	Sensitivity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method	Relapse occurring within 5 years from primary curative intervention
Primary	Specificity for relapse detection	Specificity of the test for detection of CRC relapse using radiological imaging as the reference diagnostic method	36 months disease-free
Secondary	Concordance analyses	Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points	24 months
Secondary	Test positivity	Estimation of the multi-marker test positivity for all patients and time points	24 months
Secondary	Coefficient of variation of the biomarkers	Intra- and inter-individual coefficient of variation of the biomarkers, pre- and post-surgery and during surveillance up to relapse	6 weeks
Secondary	Sensitivity for CRC detection	Sensitivity of the test for detection of primary CRC	up to 1 day prior to tumor resection