EMRISK

This is a prospective, multicentre, non-interventional observational trial performed in 2 stages for patients with primary gynaecological cancer who are requiring chemotherapy Step 1 and 2: In the first step patients will be asked to complete a questionnaire concerning their personal risk factors for nausea and emesis. The actual occurrence of these events will be documented throughout the chemotherapeutic treatment. We will try to find connections between the risk factors and the development of nausea and vomiting with the aim of creating a model for calculating the patient’s personal risk. In the second step of the study this model will be applied to a larger number of patients preceding treatment and its predictive value will be examined.

{ "short_title": "EMRISK", "data_mode": "900", "data_mode_number": "000002074", "official_title": "Development of a Risk Prediciton Model for Chemotherapy-induced Nausea and Vomiting", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "This is a prospective, multicentre, non-interventional observational trial performed in 2 stages for patients with primary gynaecological cancer who are requiring chemotherapy Step 1 and 2: In the first step patients will be asked to complete a questionnaire concerning their personal risk factors for nausea and emesis. The actual occurrence of these events will be documented throughout the chemotherapeutic treatment. We will try to find connections between the risk factors and the \r\ndevelopment of nausea and vomiting with the aim of creating a model for calculating the patient\u2019s personal risk. In the second step of the study this model will be applied to a larger number of patients preceding treatment and its predictive value will be examined.", "description_laie_en": "This is a prospective, multicentre, non-interventional observational trial performed in 2 stages for patients with primary gynaecological cancer who are requiring chemotherapy Step 1 and 2: In the first step patients will be asked to complete a questionnaire concerning their personal risk factors for nausea and emesis. The actual occurrence of these events will be documented throughout the chemotherapeutic treatment. We will try to find connections between the risk factors and the \r\ndevelopment of nausea and vomiting with the aim of creating a model for calculating the patient\u2019s personal risk. In the second step of the study this model will be applied to a larger number of patients preceding treatment and its predictive value will be examined.", "description_expert_de": "This is a prospective, multicentre, non-interventional observational trial performed in 2 stages for patients with primary gynaecological cancer who are requiring chemotherapy Step 1 and 2: In the first step patients will be asked to complete a questionnaire concerning their personal risk factors for nausea and emesis. The actual occurrence of these events will be documented throughout the chemotherapeutic treatment. We will try to find connections between the risk factors and the \r\ndevelopment of nausea and vomiting with the aim of creating a model for calculating the patient\u2019s personal risk. In the second step of the study this model will be applied to a larger number of patients preceding treatment and its predictive value will be examined.", "description_expert_en": "This is a prospective, multicentre, non-interventional observational trial performed in 2 stages for patients with primary gynaecological cancer who are requiring chemotherapy Step 1 and 2: In the first step patients will be asked to complete a questionnaire concerning their personal risk factors for nausea and emesis. The actual occurrence of these events will be documented throughout the chemotherapeutic treatment. We will try to find connections between the risk factors and the \r\ndevelopment of nausea and vomiting with the aim of creating a model for calculating the patient\u2019s personal risk. In the second step of the study this model will be applied to a larger number of patients preceding treatment and its predictive value will be examined.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 3, "sub_cat_id": 21 }