Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation (CHOPIN)

March 23, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation

The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.

The primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).

Pharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.

The secondary endpoints are

  • The detection of drug drug interactions with theriaque software, Micromedex software and DDI predictor tool.
  • The clinical gradation by an independent expert comity of the clinical impact of avoided drug drug interaction. The expert comity will grade avoided clinical consequences in 3 levels (minor, moderate or major),
  • The Economic evaluation of pharmacist intervention: Cost of the project to evaluate drug drug interaction and benefits after evaluation of avoided clinical consequences
  • The Adherence evaluation of patients treated with oral cancer targeted therapy (Therefore, only patients under oral targeted therapy will be evaluated at Day0, Day15 ,Day 30 and Month 6 to determine adherence.)

Study Type

Observational

Enrollment (Actual)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • APHP -Cochin Hospital and Georges Pompidou European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients in outpatient setting, treated in two Paris hospitals

Description

Inclusion Criteria:

  • legal age patients
  • Affiliated to social security or with another insurance system
  • with a solid tumor
  • who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)

Exclusion Criteria:

  • pregnant women
  • minor patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Pharmacist intervention
Time Frame: up to 1 week from date of inclusion
Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention
up to 1 week from date of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Drug -drug interactions
Time Frame: up to 1 week from date of inclusion
Number of drug drug interactions detected
up to 1 week from date of inclusion
Clinical gradation of drug drug interactions
Time Frame: One year
Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction
One year
Cost of the pharmacist intervention by avoided clinical consequence
Time Frame: One year
Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction
One year
Potential cost of the avoided clinical consequences
Time Frame: One year
Treatment cost of avoided clinical consequences , balanced with the probability of occurrence
One year
Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring
Time Frame: day 15, 30 and 6 months after oral therapy initiation
Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients
day 15, 30 and 6 months after oral therapy initiation
Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale
Time Frame: day 15, 30 and 6 months after oral therapy initiation
Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients
day 15, 30 and 6 months after oral therapy initiation
Adherence evaluation with oral cancer targeted therapy by pill count
Time Frame: 6 months after oral therapy initiation
Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period
6 months after oral therapy initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Audrey Thomas-Schoemann, PharmD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2020

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

October 22, 2021

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190091
  • 2018-A03512-53 (Other Identifier: Eudract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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