A Prospective, multicenter, observational study to identify deleterious novel variants of the DPYD gene in patients of non-Western descent: The DPYD-NOW study

Completed

Conditions: Cancer (breastcancer
colorectal cancer
gastric cancer)
10027656

Registration Number: NL-OMON49023

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

1. Pathologically confirmed malignancy for which treatment with a
fluoropyrimidine is considered to be in the patient*s best interest
2. Patients need to be self-declared non-Western
3. Age * 18 years
4. Able and willing to give written informed consent;
5. WHO performance status of 0, 1 or 2
6. Life expectancy of at least 12 weeks
7. Able and willing to undergo blood sampling for study related analysis
8. Adequate baseline patient characteristics (complete blood count, hepatic
function which involves serum bilirubin, AST, ALT, and renal function)

Exclusion Criteria

1. Prior treatment with fluoropyrimidines
2. Patients with known substance abuse, psychotic disorders, and/or other
diseases expected to interfere with study or the patient*s safety

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint in this study is the identification of novel variants in<br /><br>the DPYD gene in patients of non-Western descent that are associated with the<br /><br>development of severe (grade * 3) fluoropyrimidine-related toxicity and a<br /><br>reduced DPD enzyme activity measured in PBMCs.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The influence of novel DPYD variants on the variation in DPD enzyme activity<br /><br>measured in PBMCs.<br /><br>* The ability of the DPYD-varifier to predict if novel variants are deleterious<br /><br>* The frequencies of DPYD variants per ethnic origin<br /><br>* Exploration of additional genes related to severe fluoropyrimidine-related<br /><br>toxicity</p><br>