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NCT Number: NCT06607445

Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.

An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Badajoz

Badajoz, 06080, Spain

Location status: Recruiting

Location contact

Adrián LLerena, Doctor

CONTACT

[email protected]

+34 924218040

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:

General criteria for all patients:

  • Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:
  • If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
  • If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
  • Be registered or potentially/have been attended in the Extremadura Health Service.
  • Not have language or communication barrier or present disability being totally dependent on another person.

Exclusion criteria

  • Failure to meet any of the inclusion criteria described above.
  • Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
  • Manifest difficulty for follow-up.

Treatment and study plan

Primary outcomes

  1. Evaluation of the implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.

    Time frame: December 2024

    To analyze the implementation in the clinical routine of a pharmacogenetics and personalized medicine program in SES patients, evaluating the overall impact on the health system, and at the individual level, general modifications in the clinical response and its temporal evolution.

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Universitario de Badajoz

Other

Registry information

Official study title

Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service. Population Cohort [MedeA21].

Acronym: MedeA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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