Relapse Markers for Colorectal Cancer (RELMA-C)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

• Study Contact: Name: Laura Ciarloni; Phone Number: +41 21 552 0736; Email: laura.ciarloni@novigenix.com
• Study Contact Backup: Name: Matilde D'Asaro; Phone Number: +41 21 552 0736; Email: matilde.dasaro@novigenix.com

Study Locations

• Belgium
  • Leuven, Belgium
    • Department of Gastroenterology, Digestive Oncology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll CRC patients into 4 study groups. G1: patients with an actual diagnosis of CRC relapse. G2: patients declared disease-free for at least 36 months but less than 5 years.

G3: stage III-IV CRC patients who underwent a curative treatment and are disease-free after primary treatment for more than 3 but less than 18 months.

G4: patients diagnosed with primary CRC without any cancer treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
G1, CRC Relapse; Patients with an actual relapse of CRC, within 5 years from primary surgery. A single blood sample is collected at relapse diagnosis.
G2, CRC Disease-free; Patients previously diagnosed with CRC and declared disease-free for at least 36 months but less than 5 years. A single blood sample is collected at standard monitoring visit.
G3, CRC Disease-free (longitudinal); Patients declared disease-free for at least 3 months but less than 18 months. Longitudinal blood samples will be collected during standard monitoring visits up to relapse, or for a maximum of 4 time points.
G4, Primary CRC (longitudinal); Patients with an actual diagnosis of CRC who are eligible for a treatment with curative intent. Blood samples will be collected pre and post-surgery (~6 weeks) and, eventually, at relapse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance analyses	Concordance analyses between the multi-marker and Carcinoembryonic Antigen (CEA) test for all patients and time points	24 months
Test positivity	Estimation of the multi-marker test positivity for all patients and time points	24 months
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
Sensitivity for CRC detection	Sensitivity of the test for detection of primary CRC	up to 1 day prior to tumor resection

Collaborators and Investigators

• Sponsor: Novigenix SA
• Investigators: Study Director: Laura Ciarloni, Novigenix SA; Principal Investigator: Sabine Tejpar, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: S64663

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No