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CompletedNCT04142567CHOPINUpdated Mar 27, 2026

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

An observational study in Neoplasm, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
440
Ages
18 Years and older
Sex
All
01

Study 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.

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.)
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Conditions studied

  • Neoplasm

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Keywords

  • Drug drug interactions
  • Pharmacist interventions
  • Cancer patients
  • Out patient setting
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 440 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cancer patients in outpatient setting, treated in two Paris hospitals

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

Exclusion Criteria:

  • pregnant women
  • minor patient
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
440 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of Pharmacist intervention

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

    Time frame: up to 1 week from date of inclusion

Secondary outcomes

  1. Detection of Drug -drug interactions

    Number of drug drug interactions detected

    Time frame: 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

    Time frame: 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

    Time frame: One year

  4. Potential cost of the avoided clinical consequences

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months after oral therapy initiation

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Study locations

1 site
  • APHP -Cochin Hospital and Georges Pompidou European Hospital
    Paris, 75014, France
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04142567
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Feb 11, 2020
Primary completion
Apr 23, 2021
Completion
Oct 22, 2021
Last update
Mar 27, 2026

Study contacts

Audrey Thomas-Schoemann, PharmD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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