Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS

NCT02229916 | Recruiting DMC

• 1 other identifier: SG359/13
• Study Type: observational
• Target: 6,900
• Locations: 1 country
• Sites: 1

Brief Summary

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

Testicular Neoplasms

Keywords

Testicular Neoplasms; Testicular Cancer; Cohort Study

Outcome Measures

Primary Outcomes (1)

• Mode of relapse detection

  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.

  8 years

Secondary Outcomes (9)

• Rate of relapses detected on chest x-ray in seminoma patients

  8 years

• Rate of false positive abnormalities on CT scan

  8 years

• Rate of false positive tumour marker elevations not due to seminomatous or non-seminomatous germ cell tumour relapses but due to other reasons

  8 years

• Patient characteristics at baseline and at the time-point of relapse detection.

  8 years

• Rate of stage I seminoma and non-seminoma patients undergoing active surveillance.

  8 years

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with testicular cancer of any type and any stage and any age (incident cases). Testicular cancers are generally classified as seminomatous (seminoma) and nonseminomatous germ cell tumours (nonseminoma) of the testis. Mixed germ cell tumours belong to the group of non-seminomas. The stage of disease and the choice of treatment (active surveillance vs. chemotherapy vs. radiotherapy) define the risk of relapse, the pattern of relapse and the long-term toxicities. Staging in testicular cancer is performed according to the American Joint Committee on Cancer (AJCC) TNM staging system for testis cancer \[46\]. Metastatic testicular cancers are classified according to the International Germ Cell Cancer Collaborative Group (IGCCCG) risk groups \[47\].

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. med. Christian Rothermundt: lead
• German Testicular Cancer Study Group: collaborator

Study Sites (1)

Kantonsspital St.Gallen; Onkologie/Haematologie

Sankt Gallen, 9007, Switzerland

RECRUITING

Related Publications (1)

• Rothermundt 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 DERIVED

Related Links

• Webpage with basic information on the cohort study and link to the electronic case report form (eCRF) portal

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Christian Rothermundt, Dr. med.

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 3, 2014
• Study Start: December 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CH (1)