title: Prognostic factors for tumor recurrence in patients with clinical stage I seminoma undergoing surveillance--protocol for a systematic review.
abstract: BACKGROUND
  Testicular cancer is primarily treated with the surgical removal of the affected testis. About 50% of testicular cancer patients present with a stage I seminoma. If no chemo- or radiotherapy as adjuvant treatment is initiated after orchiectomy, 15-20% of these patients will develop metastases. Although adjuvant treatment is effective in reducing the relapse risk, there is rising concern about overtreatment of these patients. Prognostic factors at primary diagnosis might have the potential to identify patients at higher risk of tumor relapse, allowing to guide individual therapy and to avoid overtreatment. Therefore, we aim to synthesize the available evidence on tumor or patient characteristics as possible prognostic factors for cancer recurrence in patients with clinical stage I seminoma.
  
  
  METHODS
  We will conduct a broad systematic review to analyze what prognostic factors predict cancer recurrence in patients with a first time diagnosis of clinical stage I seminoma, who received no adjuvant chemo- or radiotherapy after orchiectomy. The literature search will comprise MEDLINE, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), and the conference proceedings of the American Society of Clinical Oncology (ASCO), American Urologic Association (AUA), and European Urologic Association (EAU) Annual Meetings. Prospective and retrospective longitudinal studies reporting on prognostic factors for cancer recurrence will be considered. We will consider the wealth of any candidate clinical or pathological prognostic factor reported in the literature. Our outcome of interest will be tumor recurrence at a minimum of 2 years follow-up. Study screening, data extraction, and quality assessment will be done by two reviewers independently. Hazard ratios will be used to measure the relationship between the potential prognostic factor and tumor recurrence. Meta-analyses will be conducted with sufficiently homogeneous studies and separately with respect to study design, by using the random-effects generic inverse variance model.
  
  
  CONCLUSIONS
  Limitations and strengths will be discussed in our review, and the results will be put into context with other studies in this field. Our results will help to guide evidence-based decision-making on patients with clinical stage I seminoma, allowing a better adjustment of therapies with regard to the individual patient's risk. Our findings will furthermore help to formulate recommendations for future research.
  
  
  BACKGROUND
  PROSPERO CRD42014009434.
authors.affiliation: Department of Urology, University Hospital of Erlangen, Erlangen, Germany. frank.kunath@uk-erlangen.de.|UroEvidence@Deutsche Gesellschaft für Urologie, Berlin, Germany. frank.kunath@uk-erlangen.de.
authors.forename: Frank
authors.initials: F
authors.lastname: Kunath
authors.affiliation: Department of Urology, University Hospital of Munich, Munich, Germany. annabel.spek@med.uni-muenchen.de.|UroEvidence@Deutsche Gesellschaft für Urologie, Berlin, Germany. annabel.spek@med.uni-muenchen.de.
authors.forename: Annabel
authors.initials: A
authors.lastname: Spek
authors.affiliation: Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany. jensen@imbi.uni-heidelberg.de.
authors.forename: Katrin
authors.initials: K
authors.lastname: Jensen
authors.affiliation: Department of Urology, University Hospital of Ulm, Ulm, Germany. friedemann.zengerling@uniklinik-ulm.de.|UroEvidence@Deutsche Gesellschaft für Urologie, Berlin, Germany. friedemann.zengerling@uniklinik-ulm.de.
authors.forename: Friedemann
authors.initials: F
authors.lastname: Zengerling
authors.affiliation: UroEvidence@Deutsche Gesellschaft für Urologie, Berlin, Germany. schmidt@dgu.de.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schmidt
mesh_terms: D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000473:pathology* / Q000628:therapy; D011379:Prognosis; D012008:Recurrence; D012107:Research Design; D012307:Risk Factors; D018239:Seminoma / Q000473:pathology* / Q000628:therapy; D000078202:Systematic Reviews as Topic; D013736:Testicular Neoplasms / Q000473:pathology* / Q000628:therapy