Early Detection of Relapses in Stage IV Colorectal Cancer Patients

NCT04232891 | Unknown DMC

• 1 other identifier: 017-FPO18
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 2

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

Conditions

Metastatic Colorectal Cancer

Keywords

liquid biopsy; metastatic colorectal cancer; early detection of metastases

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• minimal residual disease detection rate

  up to 40 days after surgery

Interventions

liquid biopsy DIAGNOSTIC_TEST

detection of tumor DNA alteration in cf-DNA

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

Metastatic colorectal cancer patients eligible to metastasectomy

You may qualify if:

• 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.
• Planned primary treatment at one of the REDCLOUD participating hospital centers.
• Evidence of at least one measurable lesion, as per RECIST 1.1.
• Male or female ≥ 18 years of age at time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. No prior chemotherapy neither for localized nor for metastatic disease.
• No major comorbidities that would preclude the compliance with the planned therapeutic program as judged by the Investigator.
• Life expectancy \> 3 months.
• Availability of biological samples (blood and tumor tissue).
• Patients enrolled in local prospective protocols, in which samples have been collected according REDCLOUD procedures may be included.
• Signed and dated informed consent.

You may not qualify if:

• Any physical or medical condition that would contraindicate chemotherapy and/or surgery.
• Any other metastatic site, except for liver and lung metastases
• Transplant recipients
• Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing will only be conducted in jurisdictions specifically requiring it.
• Known active hepatitis B or hepatitis C infection.
• Pregnant or lactating women
• 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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (2)

Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo

Candiolo, Torino, 10060, Italy

RECRUITING

Ospedale Mauriziano

Torino, 10128, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Liquid Biopsy

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Dario Ribero, MD

CONTACT

+39011993; dario.ribero@ircc.it

Cosimo Martino, PhD

CONTACT

+39011993; cosimo.martino@ircc.it

Study Design

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

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: November 18, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2023
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

IT (2)