Ireland
--:--IST
Starting soon Observational

Genetic and Epigenetic Determinants of Response to Fluorouracil-based Adjuvant Chemotherapy in Patients With Stage III Colorectal Cancer

NCT03127111 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2022-12-01
Last updated
2022-03-15

Condition(s) studied

Stage III Colorectal Cancer

Investigational drug(s) / intervention(s)

Gene mutations analysisGene methylation analysisGene expression analysisSNP analysisProtein expression analysis

Gene mutations analysis: Genomic DNA extracted from paired fresh-frozen tumor and normal tissues is used for KRAS mutations, BRAF mutations, PIK3A mutations, and EGFR mutations, etc., by sequencing and for MSI analysis by PCR and capillary electrophoresis.

Gene methylation analysis: Genomic DNA extracted from paired fresh-frozen tumor and normal tissues is used for specific gene methylation or CIMP status analysis by MethyLight or bisulfite sequencing. Whole-genome bisulfite sequencing will be used to identify novel candidate set of predictive markers.

Gene expression analysis: RNA extracted from paired fresh-frozen tumor and normal tissues or serum is used for specific gene expression analysis by real-time reverse-transcription PCR (RT-qPCR). RNA-seq will be used to identify novel candidate set of predictive markers.

SNP analysis: Genomic DNA extracted from serum is used for specific SNP analysis by using sequencing. GWAS with SNPs array will be used to identify novel candidate set of predictive markers.

Protein expression analysis: Tissue microarray made from formalin-fixed paraffin-embedded (FFPE) paired tumor and normal tissues is used for specific protein expression analysis by immunohistochemistry staining.

Study summary

The goal of this laboratory research is to look for genetic and epigenetic markers that can predict which patients with stage III colorectal cancer will benefit from fluorouracil-based adjuvant chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Requirements for tumor parameters 1. Histologically confirmed colorectal adenocarcinoma. 2. Stage III disease (any pT, N1-2, M0). 3. Tumors must have been curatively resected (R0). 4. No evidence of residual involved lymph node disease or metastatic disease at the time of registration. 2. Requirements for patient characteristics 1. Patient is ≥ 18 years of age on the day of consenting to the study. 2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at the time of screening. 3. Fertile patients must use effective contraception. 4. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document. 5. Patients must demonstrate ability to complete study questionnaires. 6. Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up. 3. Required initial laboratory values 1. Leukocytes ≥ 3,000/mm\^3 2. Absolute neutrophil count ≥ 1,500/mm\^3 3. Platelet count ≥ 100,000/mm\^3 4. Creatinine ≤ 1.5 times upper limit of normal (ULN) 5. Total Bilirubin ≤ 1.5 times ULN 6. Aspartate aminotransferase (AST) ≤ 2.5 times ULN 7. Alanine aminotransferase (ALT) ≤ 2.5 times ULN Exclusion Criteria: 1. Patients with a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluorouracil. 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection-requiring intravenous antibiotics, or psychological, familial, sociological, or geographical condition that would limit compliance with study requirements 3. Following cardiovascular conditions within the past 6 months: Myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, cerebrovascular accident or transient ischemic attack, deep vein thrombosis, other significant thromboembolic event. 4. Known human immunodeficiency virus (HIV)-positive patients and those with known hepatitis B or C. 5. Patients with evidence of other primary malignancies within the past 5 years, excluding adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. 6. Pregnant or nursing.

Primary outcome measure(s)

  • Time to recurrence (TTR) — 3 years after surgery
    Time to any event, except non-cancer-related death. All recurrences, treatment-related deaths, second same or other primary cancers, and deaths from other cancers are considered to be events. Loss to follow-up and non-cancer-related deaths are censored. Associations between TTR and genetic and epigenetic markers will be analyzed.

Trial sites (1)

FacilityCityRegionStatus
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University Wuhan Hubei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03127111 on ClinicalTrials.gov ↗ ← All trials in China