- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537833
Association Between Proton Pump Inhibitors and Hematologic Toxicity of Pemetrexed (IPPEM)
Association Between Proton Pump Inhibitors and the Incidence of Hematologic Toxicity of Pemetrexed: a Prospective, Multicenter, Observational and Longitudinal Study Among Patients Treated by a Pemetrexed-based Chemotherapy
Study Overview
Status
Intervention / Treatment
Detailed Description
Prospective, longitudinal, multicenter and observational study. All eligible patients will receive clear information about aims and research modalities on the medical consultation and before first course of chemotherapy. If patient agrees with study aims and protocol, disease and therapeutic management will not be change.
Research agree and participation leads to
Data collection:
Clinical data: weight, height, body mass index
- Demographic data: sociodemographic data, comorbidities
- Disease data: related to tumor disease and antineoplastic protocol including adjuvant medications like antiemetic of antidiarrheal agents for example.
- complete medication review: a minimum of 3 information sources among the patient and/or family and close, patient health records, community pharmacy, general practitioner,
- activation of a specific study patient record
- biologic data collection: blood count and thrombocythemia during all period study and three week after patient study completion,
- supplementary data in case of hematologic toxicity: hospitalization, growth factors (like erythropoietin and/or granulocyte colony-stimulating factor use), blood transfusions, intravenous iron, chemotherapy treatment delay All patients are followed since inclusion and for 18 months. Research logistic Patients will be recruited in cancer hospital service where patients received pemetrexed in the four study participant centers. Full information and all necessary clarification about study will be explained to all eligible patients with an appropriate consent form. Data collection using case report form will be performed by pharmacists and physicians from hospitalization setting.
Recruiting duration period Twelve months
Subject duration period Eighteen months Subject accessibility Patients will be recruited in one of the four participant centers Statistical analysis Number of patients to include with statistical considerations
It is planned to include 100 patients per group after calculating the number of subjects required (nQuery software) taking into account the following assumptions:
- Risk alpha = 0.05
- Statistical power = 90%
- Percentage of patients without hematologic toxicity in PPI-negative group = 0.62
- Percentage of patients without hematologic toxicity in PPI-positive group = 0.88 (Hazard ratio = 3.74) Statistical analysis methods of criteria Data description will be performed using mean and standard deviation or median (interquartile interval and minimum and maximum) for quantitative variables according to variable distribution and number and percentage for qualitative variables.
Bivariate analysis will be conducted in order to found the association between hematological toxicity or not and clinical variables. Multivariate analysis will be performed with Cox model, using a dependent variable "presence or not of a hematologic toxicity" and independents variables, variables that are associated with a "p" less than 0.20 with confusion factors adjustment.
Treatment of missing data The study will be performed in order to minimize the number of missing data. For each variable number and percentage of missing data will be described.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Reims, France, 51092
- CHU Reims
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria :
- Patients who receive a pemetrexed-based chemotherapy regimen for the treatment of non-small cell lung cancer (NSCLC) or mesothelioma,
- Patients who consent to participate,
- Patients for whom it is possible to characterize the consumption of proton pump inhibitors with name of the PPI and dosage.
Exclusion criteria :
- Patients who receive pemetrexed out of intravenous of for another condition than NSCLC or mesothelioma
- Patients under 18 or who refused the participation in the data collection,
- Patient previously treated by a pemetrexed-based chemotherapy,
- Patients who first receive a pemetrexed-based regimen with an initial dose adjustment (<500 mg/m²)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
"PPI-positive" or "test group"
Patients treated with PPI
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hematological toxicity will be found on biologic data the day or the day before chemotherapy.
Classification will based on NCI-CTCAE criteria
|
"PPI-negative" or "control group"
Patients not treated with PPI
|
hematological toxicity will be found on biologic data the day or the day before chemotherapy.
Classification will based on NCI-CTCAE criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between PPI consumption and pemetrexed-related hematological toxicity (grade ≥ 3)
Time Frame: Day 0
|
The hematological toxicity will be found on biologic data the day or the day before chemotherapy.
Classification will based on NCI-CTCAE criteria
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO18047*
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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