Swiss Austrian German Testicular Cancer Cohort Study – SAG TCCS

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Swiss Austrian German Testicular Cancer Cohort Study – SAG TCCS

Condition: Testicular Neoplasms

Purpose: The majority of testicular cancer patients can be cured with cisplatin-based chemotherapy. Mortality has been reduced even more within the last 15 years due to the stringent application of standard chemotherapy followed by resection of residual disease. This is a positive development considering that testicular cancer usually affects young men. Active surveillance has become an acceptable and widely used strategy in stage I testicular cancer. Thus, it is important to follow these patients in a standardized way and to adhere to a rationale surveillance strategy. There is no international consensus regarding follow-up of testicular cancer patients. Stratification according to risks and patterns of relapse would allow to tailor follow-up schedules, aiming at early identification of relapse without causing unnecessary harm by using excessive radiation in these young long-term survivors. Follow-up procedures should not only aim at detecting relapse, but also long-term side effects from therapy, including hypogonadism, metabolic syndrome, cardiovascular disease and secondary malignancies. The Swiss Austrian German Testicular Cancer Cohort Study (SAG TCCS) will comprise consecutive newly diagnosed testicular cancer patients and is the first study to prospectively evaluate the initial indictor of relapse in testicular cancer patients, the frequency and pattern of relapse and document long-term toxicities of the treatment (cardiovascular, gonadal, hearing impairment, renal function and second malignancies) and psychosocial aspects. This cohort study will determine the relevance of each test performed routinely during follow-up. The collected data will have direct implications for the care of patients with testicular cancer and inform future adaptations of follow-up recommendations. The dataset will give information on baseline factors of testicular cancer patients patients, current treatment strategies in Switzerland, Austria and Germany, outcome and late sequelae.

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02229916

Sponsor: Dr. med. Christian Rothermundt

Primary Outcome Measures:

  • Measure: Mode of relapse detection
  • Time Frame: 8 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Rate of relapses detected on chest x-ray in seminoma patients
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Rate of false positive abnormalities on CT scan
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Rate of false positive tumour marker elevations not due to seminomatous or non-seminomatous germ cell tumour relapses but due to other reasons
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Patient characteristics at baseline and at the time-point of relapse detection.
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Rate of stage I seminoma and non-seminoma patients undergoing active surveillance.
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Overview of treatment and follow-up strategies in germ cell cancer patients in Switzerland, Austria and Germany
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Treatment sequelae following testicular cancer treatment in terms of organ function, cardiovascular risk factors, sexual health and socioeconomic aspects.
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Rate of intermediate and poor-prognosis disease at relapse.
  • Time Frame: 8 years
  • Safety Issue:
  • Measure: Rate of offspring spontaneously conceived after testicular cancer treatment.
  • Time Frame: 8 years
  • Safety Issue:

Estimated Enrollment: 6900

Study Start Date: December 2013

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Written informed consent.
  • Histologically proven seminomas or non-seminoma.
  • Seminoma: complete remission (CR) or lymph nodes (LN) < 3cm or PET negative partial remission (PR) or non-seminoma: CR.
  • Completion of treatment within the last 6 months.
  • Patient able and willing to attend for regular surveillance.

Exclusion Criteria:

  • Co-existent malignancy within 5 years.
  • Inability for any reason to comply with the trial investigations or follow-up schedules.

Location:

  • Kantonsspital St.Gallen; Onkologie/Haematologie
  • St.Gallen 9007 Switzerland

View trial on ClinicalTrials.gov

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