Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.

NCT05266300 | Completed

• 1 other identifier: R231-A14057
• Study Type: observational
• Target: 722
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the benefits of a clinical implementation of a DPYD-genotype test to patients starting treatment with fluoropyrimidines (Fluorouracil (5-FU), capecitabine, tegafur).

Conditions

Adverse Drug Event; Colon Cancer; Breast Cancer; Pancreas Cancer; Rectal Cancer; Gastric Cancer; Oesophageal Cancer; Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Rate of grade 3-5 adverse events (CTCAE) Version 5.0

  Up to 6 months

Secondary Outcomes (6)

• 5-FU or capecitabine or S1-related mortality, all patients

  Up to 6 months

• 5-FU or capecitabine or S1-related mortality, DPYD variant carriers

  Up to 6 months

• Overall mortality, all patients

  Up to 6 months

• Overall mortality, DPYD variant carriers

  Up to 6 months

• Length of hospital stay

  Up to 6 months

Study Arms (2)

Retrospective

Historic group. Patients treated in the historic control group did not receive DPYD-genotype before treatment with fluorouracil, capecitabine, tegafur. They received standard start doses of 5-FU, capecitabine, tegafur.

Prospective

Participants enrolled in the prospective group will give a blood sample for immediate DPYD genotyping. Once the results from these tests are in, the treating oncologist have immediate access to the participant's genetic test results and can make dosing decisions/changes to the participant's chemotherapy prescription. The recommended starting doses for 5-FU, capecitabine, tegafur are. No DPYD-gene variant = normal starting dose (100%) 1 DPYD-gene variant (heterozygous) = Reduced starting dose (50%) Homozygous for 1 DPYD variant or compound heterozygous (\>1 variants) = Treatment with 5-FU, capecitabine, tegafur is not recommended .

Genetic: DPYD genotype

Interventions

DPYD genotype GENETIC

The SNPs included in this study are the following (dbSNP Reference SNP) rs3918290(c.1905+1G\>A) rs67376798(c.2846A\>T) rs55886062(c.1679T\>G) rs56038477(75017182)/(c.1236G\>A)

Also known as: Dihydropyrimidine dehydrogenase (DPD) enzyme activity

Prospective

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

Cancer patients treated at The Department of Oncology at Odense University Hospital (OUH)

You may qualify if:

• Patients with cancer that are eligible for systemic treatment with 5-FU, capecitabine, or tegafur.

You may not qualify if:

• Patients that earlier have been treated with 5-FU, capecitabine, or tegafur

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

The Department of Oncology at University of southern denmark

Odense, Region Syddanmark, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for phenotype analysis.(uracil and dihydrouracil concentrations)

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Colonic Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Bile Duct Neoplasms

Interventions

Dihydrouracil Dehydrogenase (NADP)

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Rectal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Oxidoreductases Acting on CH-CH Group Donors; Oxidoreductases; Enzymes; Enzymes and Coenzymes

Study Officials

• Per Damkier, MD, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ph.d. Clinical Professor,

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: March 4, 2022
• Study Start: September 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)