Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Fluorouracil

Antimetabolites

Patients were included in this arm if they have digestive cancer and an uracil dosage \<16 ng/mL performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the four oncology departments (Hopital Edouard Heriot \[Lyon\], Centre Hospitalier de Lyon Sud \[Lyon\], Hopital de la Croix Rousse \[Lyon\].

In each group with an uracil dosage; at cycle 1; capecitabine or continuous 5-FU dose percentage will be evaluate retrospectively in our database

Fluoropyrimidine treatment (5-FU or capecitabine) and dosage

For each patient, uracil concentration will be evaluate and patients will be compared based on 16 ng/mL as threshold.

Uracil dosage

For each group of patient, on 16 ng/mL as threshold for uracil concentration, overall survival will be compared betwen the two groups of patients (Uracil \<16 vs Uracil ≥16).

Overall survival

Digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-Fluorouracil (5-FU) or capecitabine). 5-FU is mainly catabolised by dihydropyrimidine dehydrogenase (DPD) and partial or complete DPD deficiency can cause severe adverse reactions. Different strategies have been proposed to predict DPD deficiency; the two main approaches are phenotyping the enzyme activity (directly or indirectly), or genotyping the four main polymorphisms associated with 5-FU-toxicity. In February 2018, the French medicines agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) recommended DPD genotyping for all patients receiving fluoropyrimidine-based treatment to improve its safety as compared to the European Medicines Agency (EMA)13 and others pharmacogenetics working group.

In December 2018, a new guideline from the French cancer institute (Institut National Du Cancer, INCa) and the French health authority (Haute Autorité de Santé, HAS) recommended the measurement of the uracil blood level before genotyping DPD and dose adaptation if this level is greater than 16 ng/mL. The aim herein is to assess how this recommendation has been implemented in clinical routine. 5-FU displays a dose-response relationship regarding both its efficacy and its toxicity, did tailored-dose impair the treatment efficacy as it decreased the risk of toxicity? To address that matter we conducted a retrospective study to evaluate how fluoropyrimidine dosage is adapted to uracil concentration with an emphasis on how patients outcome were affected. We compared time to failure and overall survival between patients with an uracil concentration \< 16 ng/mL and \> or = 16 ng/mL.

Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice

Hospices Civils de Lyon

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Lymphoma

Lymphoma, B-Cell

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

B-cell Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Bernadette Verogen, DR

Oriana Nanni

Alfredo Molteni

Stefano Molica

Claudio Cerchione, MD

Matteo Piccini

Nicola Cascavilla

Vincenza Martini

Nicola Di Renzo

Giuseppe Cimino

Monica Fumagalli

Roberto Cairoli

Prassede Salutari

Maria Paola Martelli

Carmine Selleri, MD

Monica Bocchia

Ernesta Audisio, MD

Alessandro Cignetti

Michele Gottardi, MD

Elisabetta Todisco, MD

Nicola Fracchiolla, MD

Elisabetta Abruzzese, MD, PhD

Giovanni Martinelli, MD

This is a multi-center retrospective observational study. Every patient with Acute Myeloid Leukemia (AML) treated with anti-B-cell lymphoma 2 (BCL2) treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study.

In phase 1-2 studies, anti BCL-2 treatment has shown evidence of anti-leukemic activity as single agent and in combination and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2015 anti-BCL2 treatment has been available in other indications and in off-label use in Italy.

In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with AML, to improve the knowledge about anti-BCL2 treatment in clinical practice. Collecting and analyzing data from a large unbiased patient-set receiving anti-BCL2, would enlarge our knowledge on therapies inhibiting BCL2.

This is a multi-center retrospective observational study. Every patient with AML treated with anti-BCL2 treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study. As this study is intended to be purely observational (not interventional), the patient's medical records will be the source of all data to be recorded. No additional procedures/patient visits should be planned in the study with respect to clinical practice.

Clinical data (treatment, survival, adverse events) will be collected for patients enrolled.

Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting BCL-2

Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting B-cell Lymphoma 2 (BCL-2)

To evaluate the toxicity profile of the therapy with anti-BCL-2 in patients with AML.

to describe the clinical outcomes in terms of Overall Survival (OS) defined as the number of days between the first study drug administration and death from any cause

to describe Disease Free Survival, defined as the number of days between the first study drug administration and any event including disease progression or death from any cause (both median and restricted mean) whichever occurs first.

to describe the Complete Remission (CR), in terms of proportions, in response to therapy

to describe Complete Remission with incomplete hematologic recovery (CRi) in terms of proportions, in response to therapy

to describe Minimal Residual Disease, in terms of proportions, in response to therapy

to describe the incidence of successful bridge to allogeneic transplant, in terms of proportions, in response to therapy

to describe healthcare resource utilization in terms of number of hospitalizations per patient

to describe healthcare resource utilization in terms of days of hospitalizations per patient

to describe healthcare resource utilization in terms of number of clinical visits per patient

to describe healthcare resource utilization in terms of number of accesses in Day Hospital per patient

to describe healthcare resource utilization in terms of number of accesses in Emergency Care Units per patient

European Institute of Oncology

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Participants complete patient-reported outcome (PRO) questionnaires. Care providers do have access to the PROs and use them in clinical decision making.

The participants complete patient-reported outcome (PRO) questionnaires. Care providers do not have access to the PROs.

Standard follow-up. The participants do not complete PRO questionnaires.

Patient-reported outcome (PRO) questionnaires are completed at home within one week before a patient-physician consultation at the outpatient clinic. The questionnaires are submitted online or on paper depending on the participants choice.

Completion of patient-reported outcome (PRO) questionnaires

Nana Brochmann, MD

Hans Hasselbalch, professor

This study investigates if integration of patient-reported outcomes in the follow-up of patients with newly diagnosed, not curable, chronic hematological cancer changes the number and kind of supportive care interventions. Furthermore, this study investigates if the patients feel that they are more involved in a positive way when patient-reported outcomes are integrated in the follow-up of their cancer.

This is a multimethod study. It has a quantitative and a qualitative part. The patient-reported outcome questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30) and the patient-reported outcome and patient-reported experience questionnaire The Outcomes and Experiences Questionnaire (OEQ) are completed by the included patients within one week before a patient-physician consultation at the outpatient clinic at one single department of hematology. Baseline is different for different patient groups; 1) for participants receiving a primary treatment baseline is defined as the first patient-physician consultation after the primary treatment ended, 2) for patients continuously receiving medical treatment baseline is defined as the first patient-physician consultation after starting medical treatment, and 3) for patients followed using a watch and wait strategy baseline is defined as the first patient-physician consultation after deciding the watch and wait strategy. Each patient completes the questionnaires for 2 years. The questionnaires can be completed online or on paper depending on the patients choice. Answers from both questionnaires are eligible to all health care professionals in the outpatient clinic in an internet-based tool. A summary of scores from the EORTC QLQ C-30, and the answers and the score from the OEQ, are written in the medical record.

This study investigates, if use of the patient-reported outcome (PRO) questionnaires are useful in the assessment of the patients needs and health care providers decision making regarding supportive care interventions. It investigates, if completion of PRO questionnaires changes the number and kind of supportive care interventions.

Observations of patient-physician consultations and individual interviews with patients are used to capture the impact of the questionnaires on the consultations and patients evaluation of the use of the questionnaires.

This study also investigates, if patients completion of PRO questionnaires and health care professionals use of the questionnaires in clinical decision making changes the number of contacts between patients and a department of hematology and the number of paraclinical interventions.

In one randomization arm the participants submit patient-reported outcomes, and the care providers have access to the patient-reported outcomes. In another randomization arm the participants submit patient-reported outcomes, but the care providers do not have access to the patient-reported outcomes. In the last randomization arm the participants are randomized to standard follow-up, do not complete PRO questionnaires and are thus controls.

Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer

Number and kind of supportive care interventions are registered. Supportive care actions are defined as: a) a plan for rehabilitation, b) an intervention by a physiotherapist, occupational therapist, dietician, or social worker, c) consultation with a psychologist or talk with a priest, d) an intervention done by a general practitioner because of the hematological cancer after contact between the hematological department and the general practitioner, e) use of offers like group talks etc offered by the Danish Cancer Society, or f) other supportive care interventions

Patients satisfaction with the interventions done by a department of hematology are measured using a patient-reported experience questionnaire

The impact of the use of PRO questionnaires on the consultation and patients satisfaction with and evaluation of the use of patient-reported outcomes in the outpatient clinic are investigated by observation of conversations between doctors and patients in the outpatient clinic, and furthermore investigated by individual interviews

All contacts between the patients and the department of hematology are registered. Are there more/less/equal number and kind of contacts to the outpatient clinic at department of hematology when using patient-reported outcomes compared to when not using patient-reported outcomes?

All paraclinical actions ordered by the department of hematology are registered. Are more/less/equal number and kind of paraclinical interventions done when using patient-reported outcomes compared to when not using patient-reported outcomes?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice	NCT04918264	Digestive Carci...	Fluoropyrimidin... Uracil dosage Overall surviva...	18 Years -	Hospices Civils de Lyon
Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting BCL-2	NCT04070807	Acute Myeloid L...		18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer	NCT03056469	Hematological C...	Completion of p...	18 Years - 100 Years	Zealand University Hospital

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