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Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS (SAG TCCS)

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ClinicalTrials.gov Identifier: NCT02229916
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
German Testicular Cancer Study Group
Information provided by (Responsible Party):
Dr. med. Christian Rothermundt, Cantonal Hospital of St. Gallen

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.

Condition or disease
Testicular Neoplasms

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
Official Title: Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS
Study Start Date : December 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mode of relapse detection [ Time Frame: 8 years ]
    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 Outcome Measures :
  1. Rate of relapses detected on chest x-ray in seminoma patients [ Time Frame: 8 years ]
  2. Rate of false positive abnormalities on CT scan [ Time Frame: 8 years ]
  3. 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 ]
  4. Patient characteristics at baseline and at the time-point of relapse detection. [ Time Frame: 8 years ]
  5. Rate of stage I seminoma and non-seminoma patients undergoing active surveillance. [ Time Frame: 8 years ]
  6. Overview of treatment and follow-up strategies in germ cell cancer patients in Switzerland, Austria and Germany [ Time Frame: 8 years ]
  7. Treatment sequelae following testicular cancer treatment in terms of organ function, cardiovascular risk factors, sexual health and socioeconomic aspects. [ Time Frame: 8 years ]
  8. Rate of intermediate and poor-prognosis disease at relapse. [ Time Frame: 8 years ]
  9. Rate of offspring spontaneously conceived after testicular cancer treatment. [ Time Frame: 8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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].

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229916


Locations
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Switzerland
Kantonsspital St.Gallen; Onkologie/Haematologie Recruiting
St.Gallen, Switzerland, 9007
Contact: Christian Rothermundt, Dr. med.    +41 71 494 11 11    christian.rothermundt@kssg.ch   
Principal Investigator: Christian Rothermundt, Dr. med.         
Sponsors and Collaborators
Dr. med. Christian Rothermundt
German Testicular Cancer Study Group
Investigators
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Principal Investigator: Christian Rothermundt, Dr. med. Cantonal Hospital of St. Gallen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Christian Rothermundt, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02229916    
Other Study ID Numbers: SG359/13
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2019
Keywords provided by Dr. med. Christian Rothermundt, Cantonal Hospital of St. Gallen:
Testicular Neoplasms
Testicular Cancer
Cohort Study
Additional relevant MeSH terms:
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Testicular Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders