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NeoplasmCHOPINNCT04142567

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

An observational study of Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm
How many people
440 participants
Where
1 siteFrance
Study dates
11 Feb 2020to 22 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cancer patients in outpatient setting, treated in two Paris hospitals

Who may be able to join

  • 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)

Who cannot join

  • pregnant women
  • minor patient

Trial locations and contacts

1 site in 1 country.

France1 site

  • APHP -Cochin Hospital and Georges Pompidou European Hospital

    Paris, 75014

Other trials in France

About this study

Official title: 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

Read the 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.)
Conditions
Neoplasm
Keywords
Drug drug interactions, Pharmacist interventions, Cancer patients, Out patient setting
Medical subject headings
Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Pharmacist intervention

    Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention

    Measured: up to 1 week from date of inclusion

Secondary outcomes (7)

  1. Detection of Drug -drug interactions

    Number of drug drug interactions detected

    Measured: up to 1 week from date of inclusion

  2. Clinical gradation of drug drug interactions

    Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction

    Measured: One year

  3. Cost of the pharmacist intervention by avoided clinical consequence

    Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction

    Measured: One year

  4. Potential cost of the avoided clinical consequences

    Treatment cost of avoided clinical consequences , balanced with the probability of occurrence

    Measured: One year

  5. Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring

    Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients

    Measured: day 15, 30 and 6 months after oral therapy initiation

  6. Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale

    Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients

    Measured: day 15, 30 and 6 months after oral therapy initiation

  7. Adherence evaluation with oral cancer targeted therapy by pill count

    Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period

    Measured: 6 months after oral therapy initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start11 Feb 2020
  3. Primary completion23 Apr 2021
  4. Study completion22 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142567
Sponsor's protocol ID
APHP190091
Other IDs
2018-A03512-53
Acronym
CHOPIN
Status last verified
Mar 2026
First submitted
4 Sep 2019
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thomas-Schoemann A, Blanchet B, Bardin C, Noe G, Boudou-Rouquette P, Vidal M, Goldwasser F. Drug interactions with solid tumour-targeted therapies. Crit Rev Oncol Hematol. 2014 Jan;89(1):179-96. doi: 10.1016/j.critrevonc.2013.08.007. Epub 2013 Aug 28.

    PubMed 24041628

  • P. Boudou Rouquette, A. Thomas-Schoemann, A. Chahwakilian et al., Clinical benefit of a one-day multidisciplinary work-up for risk assessment in unfit cancer patients. ESMO congress, abstract 1558; Amsterdam 2013

  • Bonnet C, Boudou-Rouquette P, Azoulay-Rutman E, Huillard O, Golmard JL, Carton E, Noe G, Vidal M, Orvoen G, Chah Wakilian A, Villeminey C, Blanchet B, Alexandre J, Goldwasser F, Thomas-Schoemann A. Potential drug-drug interactions with abiraterone in metastatic castration-resistant prostate cancer patients: a prevalence study in France. Cancer Chemother Pharmacol. 2017 May;79(5):1051-1055. doi: 10.1007/s00280-017-3291-z. Epub 2017 Mar 30.

    PubMed 28361167

  • Lees J, Chan A. Polypharmacy in elderly patients with cancer: clinical implications and management. Lancet Oncol. 2011 Dec;12(13):1249-57. doi: 10.1016/S1470-2045(11)70040-7. Epub 2011 Jul 6.

    PubMed 21741307

  • Riechelmann RP, Tannock IF, Wang L, Saad ED, Taback NA, Krzyzanowska MK. Potential drug interactions and duplicate prescriptions among cancer patients. J Natl Cancer Inst. 2007 Apr 18;99(8):592-600. doi: 10.1093/jnci/djk130.

    PubMed 17440160

  • Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):56-66. doi: 10.3322/caac.20004.

    PubMed 19147869

  • Giraud JS, Korb-Savoldelli V, Perrin G, Jouinot A, Sabatier B, Batista R, Ribault M, De Percin S, Villeminey C, Videau M, Blanchet B, Goldwasser F, Degrassat-Theas A, Thomas-Schoemann A. Clinical and economic impact of pharmacist interventions to identify drug-related problems in multidisciplinary cancer care: a prospective trial. Oncologist. 2025 Aug 4;30(8):oyae213. doi: 10.1093/oncolo/oyae213.

    PubMed 39403043

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Pharmacist intervention (time frame: up to 1 week from date of inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04142567, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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