Relapse Markers for Colorectal Cancer

NCT04920955 | Completed

• 1 other identifier: S64663
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Concordance analyses

  24 months

• Test positivity

  24 months

• Coefficient of variation of the biomarkers

  6 weeks

• Sensitivity for CRC detection

  up to 1 day prior to tumor resection

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Personal history of cancer (non-hematologic) other than CRC in complete remission for less than 5 years.
• Personal history of hematologic cancer.
• 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.
• 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.

Sponsors & Collaborators

• Novigenix SA: lead

Study Sites (1)

Department of Gastroenterology, Digestive Oncology Unit

Leuven, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral whole blood and Plasma

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Laura Ciarloni

  Novigenix SA

  STUDY DIRECTOR

• Sabine Tejpar

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 10, 2021
• Study Start: February 10, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

BE (1)