Early Detection of Relapses in Stage IV Colorectal Cancer Patients

Metastatic Colorectal Cancer Clinical Trial

— REDCLOUD  

Official title:

Early Detection of Relapses in Stage IV Colorectal Cancer Patients: REDCLOUD (REsidual Disease, Colorectal Cancer, Liquid biOpsy Detection)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232891
• Other study ID #: 017-FPO18
• Status: Recruiting
• Start date: November 18, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2020
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Dario Ribero, MD
• Phone: +39011993
• Email: dario.ribero[@]ircc.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Diagnostic Test:
• liquid biopsy
detection of tumor DNA alteration in cf-DNA

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo	Candiolo	Torino
Italy	Ospedale Mauriziano	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse rate in MRD+ patients	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.	immediately surgery and up to 2 years after surgery
Primary	relapse rate in MRD- patients	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.	immediately surgery and up to 2 years after surgery
Secondary	minimal residual disease detection rate	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.	up to 40 days after surgery