SOGUG-AVELUMAB_RWD
Condition: Metastatic Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Observational

Summary: 
      The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first
      line maintenance therapy in patients with locally advanced or metastatic Urothelial
      Carcinoma, who have not progressed after first line platinum-based treatment.

      Study is performed at national hospitals from approximately 22 different sites and expecting
      to recruit 120 patients.

      Patients understanding the nature of the study by providing their informed consent prior to
      participation.

        -  Patients of both sexes diagnosed with locally advanced or metastatic Urothelial
           Carcinoma, stage IV disease before first line with carboplatin/cisplatin-based
           chemotherapy. No disease progression after four-six cycles of ChT according to the
           Response Evaluation Criteria in Solid Tumor with a treatment free interval of 4-10 weeks
           before Avelumab initiation date.

        -  Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021
           and before 27/Apr./2022 (both dates included).
    

Detailed description: 
      Multicentre, observational, ambispective (retrospective and prospective) study to evaluate
      the real-world evidence of Avelumab as maintenance therapy in patients diagnosed with
      Urothelial Carcinoma (WHO classification) and previously treated with platinum-based
      treatment in first line. Study is performed at national hospitals from approximately 22
      different sites and expecting to recruit 120 patients. Patients are selected based on the
      existing medical record of have been treated with Avelumab as maintenance therapy in first
      line before initiating the study (retrospective data); patients who continues receiving
      Avelumab after inclusion will also contribute to data collection until the end of treatment
      or end of study (prospective data).

      According to mUC incidence and the selective inclusion criteria from this study of having
      initiated Avelumab as maintenance therapy in 1L between EMA approval date (Jan. 2021) and
      date of national reimbursement prize (Apr.2022), which is a narrow period of time to recruit
      the necessary number of candidates, therefore, prospective data from each participant patient
      will be a key to ensure the assessment of the study objective eventually.

      Investigators will review the medical history of patients treated or under treatment of
      Avelumab and select chronologically those who matches the inclusion criteria. Patients will
      be informed during a regular follow up visit about the nature of the study and requested to
      sign the patient consent form once the decision of participating is made. At this point, the
      retrospective data from patients is collected (such as demographics, toxicity,
      anthropometrics, vital signs, comorbidities, hemogram, dosage modification etc.) previous
      adverse reactions (ARs) and serious adverse reaction (SARs) related to Avelumab. Included
      patients, that continues under Avelumab treatment will be monitored by investigators and
      prospective data from them will be collected during follow up visits and/or from electronic
      medical records (eMR).

      Deceased patient who fulfils the inclusion criteria can be also included, being able to
      access to its clinical data at the beginning of the study according to Regulation (EU)
      2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of
      natural persons with regard to the processing of personal data and on the free movement of
      such data, and repealing Directive 95/46/EC (General Data Protection Regulation) and the
      Spanish Organic Law 3/2018 of 5th December, on the protection of personal data and digital
      rights. Additionally, the investigator team will consult in the eMR of deceased patients to
      ensure that they did not express in life opposition to the use of their data for
      investigational purposes.
    

Intervention name(s): Avelumab
Intervention type(s): Drug
Intervention description(s): Single Group Assignment
Intervention MeSH terms: Avelumab
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with locally advanced or metastatic Urothelial Carcinoma who have not
        progressed after first line platinum-based treatment and who received or are receiving
        Avelumab as the first-line maintenance therapy in routine clinical practice.