Personalised Therapeutics @ LUMC

Personalised Therapeutics @ LUMC - PT@LUMC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54078

Enrollment

1000

Registered

2022-04-21

Start date

2022-12-14

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geen specifieke aandoening, patienten worden voor een geplande opname geïncludeerd n.v.t.

Interventions

Patients are randomised to PGx-guided dosing or standard of care. The PGx guided group receives pre-emptive PGx testing for a panel of 13 genes (including 227 PGx variants) followed by personalised

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Provision of informed consent (IC) prior to any study specific procedures. Be aged >=18 Is able to provide a blood sample via venapunction Receive a medication verification interview Be able and willing to be followed-up for at least one year

Exclusion criteria

Exclusion criteria: Pregnancy or lactating Previous participation in the PREPARE trial (NCT03093818, NL60069.058.16) History of a liver transplantation or stem-cel transplantation

Design outcomes

Primary

Measure	Time frame
The primary outcome is the occurrence of drug-genotype associated adverse drug reactions (ADR) in the first 12 months following the genetic test. The outcome is dichotomized at >= grade 3 CTC-AE.	—

Secondary

Measure	Time frame
1. The occurrence of clinically relevant (classified as NCI-CTCAE grade 3, 4, or 5) patient reported ADRs, attributable to a PGx drug, at one, three, six and twelve months of follow-up. 2. Acceptance of the recommendations measured by comparing the number of dose adjustments and medication switches in the intervention and control arm. This will provide information about the acceptance of the different health care professionals. 3. The cost-effectiveness of a pre-emptive PGx panel test will be analysed by relating healthcare costs (including genetic testing, drugs and ADR-related care) to quality-adjusted life years (estimated using the EQ-5D-5L). 4. The occurrence of clinically relevant (classified as NCI-CTCAE grade 2, 3, 4, or 5) patient reported ADRs, attributable to a PGx drug, within one year of follow-up. 5. The occurrence of clinically relevant (classified as NCI-CTCAE grade 2, 3, 4, or 5) patient reported ADRs, attributable to a PGx drug, at one, three, six and twelve months of follow-up. 6. The frequency of PGx drug prescriptions (per PGx gene) (corrected for dose changes due to PGx outcome) within one year of follow-up.	—

Measure

Time frame

1. The occurrence of clinically relevant (classified as NCI-CTCAE grade 3, 4, or 5) patient reported ADRs, attributable to a PGx drug, at one, three, six and twelve months of follow-up. 2. Acceptance of the recommendations measured by comparing the number of dose adjustments and medication switches in the intervention and control arm. This will provide information about the acceptance of the different health care professionals. 3. The cost-effectiveness of a pre-emptive PGx panel test will be analysed by relating healthcare costs (including genetic testing, drugs and ADR-related care) to quality-adjusted life years (estimated using the EQ-5D-5L). 4. The occurrence of clinically relevant (classified as NCI-CTCAE grade 2, 3, 4, or 5) patient reported ADRs, attributable to a PGx drug, within one year of follow-up. 5. The occurrence of clinically relevant (classified as NCI-CTCAE grade 2, 3, 4, or 5) patient reported ADRs, attributable to a PGx drug, at one, three, six and twelve months of follow-up. 6. The frequency of PGx drug prescriptions (per PGx gene) (corrected for dose changes due to PGx outcome) within one year of follow-up.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)