Early Detection of Relapses in Stage IV Colorectal Cancer Patients

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT04232891
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Brief Summary

This study is a prospective, multicenter, observational study on metastatic, operable colorectal cancer to evaluate the proof of concept of the cfDNA analysis for the early detection of recurrences

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-18
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2021-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

1. Histological confirmed adenocarcinoma of the colon or rectum with synchronous metastatic disease (localized in liver or in liver and lung) eligible for surgery immediately or after neo-adjuvant treatment.
2. Planned primary treatment at one of the REDCLOUD participating hospital centers.
3. Evidence of at least one measurable lesion, as per RECIST 1.1.
4. Male or female ≥ 18 years of age at time of informed consent.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. No prior chemotherapy neither for localized nor for metastatic disease.
6. No major comorbidities that would preclude the compliance with the planned therapeutic program as judged by the Investigator.
7. Life expectancy > 3 months.
8. Availability of biological samples (blood and tumor tissue).
9. Patients enrolled in local prospective protocols, in which samples have been collected according REDCLOUD procedures may be included.
10. Signed and dated informed consent.

Exclusion Criteria

1. Any physical or medical condition that would contraindicate chemotherapy and/or surgery.
2. Any other metastatic site, except for liver and lung metastases
3. Transplant recipients
4. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing will only be conducted in jurisdictions specifically requiring it.
5. Known active hepatitis B or hepatitis C infection.
6. Pregnant or lactating women
7. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ adequately treated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relapse rate in MRD- patients	immediately surgery and up to 2 years after surgery	Percentage of patients with no MRD (minimal residual disease) with documented relapse. MRD- is defined as detection, through liquid biopsy, of no molecular alterations evaluated in any plasma sample drawn within 40 days from surgery.
relapse rate in MRD+ patients	immediately surgery and up to 2 years after surgery	Percentage of patients with MRD (minimal residual disease) with documented relapse. MRD is defined as detection, through liquid biopsy, of any of the molecular alterations evaluated in any plasma sample drawn within 40 days from surgery.

Secondary Outcome Measures

Name	Time	Method
minimal residual disease detection rate	up to 40 days after surgery	percentage of patients with detectable MRD (minimal residual disease) defined as detection, through liquid biopsy, of any of the molecular alterations evaluated in any plasma sample drawn within 40 days from surgery.

Trial Locations

Locations (2)

Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo; 🇮🇹 Candiolo, Torino, Italy

Ospedale Mauriziano; 🇮🇹 Torino, Italy