NCT04142567

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 11, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2021

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

September 4, 2019

Last Update Submit

March 23, 2026

Conditions

Keywords

Drug drug interactionsPharmacist interventionsCancer patientsOut patient setting

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Pharmacist intervention

    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 Outcomes (7)

  • Detection of Drug -drug interactions

    up to 1 week from date of inclusion

  • Clinical gradation of drug drug interactions

    One year

  • Cost of the pharmacist intervention by avoided clinical consequence

    One year

  • Potential cost of the avoided clinical consequences

    One year

  • Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring

    day 15, 30 and 6 months after oral therapy initiation

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients in outpatient setting, treated in two Paris hospitals

You may qualify if:

  • 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)

You may not qualify if:

  • pregnant women
  • minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP -Cochin Hospital and Georges Pompidou European Hospital

Paris, 75014, France

Location

Related Publications (7)

  • 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.

    PMID: 24041628BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28361167BACKGROUND
  • 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.

    PMID: 21741307BACKGROUND
  • 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.

    PMID: 17440160BACKGROUND
  • 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.

    PMID: 19147869BACKGROUND
  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Audrey Thomas-Schoemann, PharmD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

October 29, 2019

Study Start

February 11, 2020

Primary Completion

April 23, 2021

Study Completion

October 22, 2021

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations