Association Between Proton Pump Inhibitors and Hematologic Toxicity of Pemetrexed (IPPEM)
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ClinicalTrials.gov Identifier: NCT03537833 |
Recruitment Status :
Recruiting
First Posted : May 25, 2018
Last Update Posted : December 16, 2019
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Condition or disease | Intervention/treatment |
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Patients With Non-small Cell Lung Cancer (NSCLC) and Pleural Mesothelioma and Treated With a Pemetrexed-based Chemotherapy | Other: pemetrexed-related hematological toxicity |

Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | May 2, 2018 |
Estimated Primary Completion Date : | November 2, 2020 |
Estimated Study Completion Date : | May 2, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
"PPI-positive" or "test group"
Patients treated with PPI
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Other: pemetrexed-related hematological toxicity
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
|
Other: pemetrexed-related hematological toxicity
hematological toxicity will be found on biologic data the day or the day before chemotherapy. Classification will based on NCI-CTCAE criteria |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537833
Contact: Florian SLIMANO | 3 10 73 62 96 ext 0033 | fslimano@chu-reims.fr |
France | |
Chu Reims | Recruiting |
Reims, France, 51092 | |
Contact: Damien JOLLY 326788472 ext 33 djolly@chu-reims.fr |
Responsible Party: | CHU de Reims |
ClinicalTrials.gov Identifier: | NCT03537833 |
Other Study ID Numbers: |
PO18047 |
First Posted: | May 25, 2018 Key Record Dates |
Last Update Posted: | December 16, 2019 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Mesothelioma Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial |
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