Clinical trial · Observational
Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Neoplasms | Testicular Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Mode of relapse detection
- timeFrame
- 8 years
- description
- Diagnostic performance and the clinical impact of a variety of tests, including conventional radiographs, computed tomographies (CT), abdominal ultrasound, serum tumour markers (AFP, beta-HCG and LDH) and clinical signs and symptoms aimed at early detection of relapse after curative therapy with documented complete remission.
Secondary outcomes (9)
- measure
- Rate of relapses detected on chest x-ray in seminoma patients
- timeFrame
- 8 years
- measure
- Rate of false positive abnormalities on CT scan
- timeFrame
- 8 years
- measure
- Rate of false positive tumour marker elevations not due to seminomatous or non-seminomatous germ cell tumour relapses but due to other reasons
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRothermundt C, Thurneysen C, Cathomas R, Muller B, Mingrone W, Hirschi-Blickenstorfer A, Wehrhahn T, Ruf C, Rothschild S, Seifert B, Terbuch A, Grassmugg T, Woelky R, Fankhauser C, Kunit T, Fischer N, Inauen R, Kamradt J, Ziegler K, Haynes A, Juni P, Gillessen S. Baseline characteristics and patterns of care in testicular cancer patients: first data from the Swiss Austrian German Testicular Cancer Cohort Study (SAG TCCS). Swiss Med Wkly. 2018 Jul 24;148:w14640. doi: 10.4414/smw.2018.14640. eCollection 2018. PMID 30044478