Clinical trial NCT04232891: Early Detection of Relapses in Stage IV Colorectal Cancer Patients
Official title: Early Detection of Relapses in Stage IV Colorectal Cancer Patients: REDCLOUD (REsidual Disease, Colorectal Cancer, Liquid biOpsy Detection)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: liquid biopsy
metastatic colorectal cancer
early detection of metastases
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic colorectal cancer patients eligible to metastasectomy

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


Eligibility criteria: 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

Primary outcomes:
measure: relapse rate in MRD+ patients
timeFrame: immediately surgery and up to 2 years after surgery
measure: relapse rate in MRD- patients
timeFrame: immediately surgery and up to 2 years after surgery
Secondary outcomes:
measure: minimal residual disease detection rate
timeFrame: up to 40 days after surgery
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
state: Torino
city: Torino
country: Italy
facility: Ospedale Mauriziano
Study officials:
References: