The OrphAn Testis Histologies (OATH) Registry, an international registry on behalf of the Global Germ Cell (G3) consortium BASEC 2019-00011

Interested centers should please contact: christian.fankhauser@usz.ch 


Objectives

The purpose of this international registry study is to establish a database on patients with rare testicular tumors diagnosed between 1990 and 2018. The database will include the following data: i) patient characteristics at the time of diagnosis, ii) clinical and pathological risk factors for, iii) data on local and systemic treatments (e.g. surgery, chemotherapy or radiotherapy), iv) response to therapies and v) time to and extent of disease recurrence.

The database is thought to include as many patients as possible from high-volume centers around the world which evinced interest in study participation. All eligible patients from each center will be included as far as data is sufficient to answer at least one of the research questions below. The data will be collected via online case report forms (CRFs) in a retrospective design.

Primary objective:

The co-primary objectives are to identify risk factors for malignancy and validate a multivariable model for clinical decision-making.

Secondary objectives:

  • Local recurrence rates after testis sparing surgery
  • Role of adjuvant or salvage chemotherapy, radiotherapy or retroperitoneal lymphadenectomy (RPLND)
  • Timing and site relapse


Patients and methods

Inclusion criteria

  • Patients have to fulfill the following criteria to be included in the database:Male gender
  • Age ≥ 18 years
  • Histologically confirmed testicular tumor
  • Treatment between 1990 and 2018
  • Consent of the investigators at participating centers to allow site-visits and verification of data entries, if requested
  • Approval of Local Ethics Committee boards

 Exclusion criteria

  • The following criteria interdict study inclusion of a patient:Lacking data to an extent that none of the relevant research questions can be answered
  • In case of repetitive and relevant queries on data quality at a participating center or if a participating center refuses site visits for data entry verification, all patients from the according center will be excluded from the analysis.



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