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 : August 2, 2021
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|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6900 participants|
|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 2023|
|Estimated Study Completion Date :||December 2033|
- 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.
- Rate of relapses detected on chest x-ray in seminoma patients [ Time Frame: 8 years ]
- Rate of false positive abnormalities on CT scan [ Time Frame: 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 [ Time Frame: 8 years ]
- Patient characteristics at baseline and at the time-point of relapse detection. [ Time Frame: 8 years ]
- Rate of stage I seminoma and non-seminoma patients undergoing active surveillance. [ Time Frame: 8 years ]
- Overview of treatment and follow-up strategies in germ cell cancer patients in Switzerland, Austria and Germany [ Time Frame: 8 years ]
- Treatment sequelae following testicular cancer treatment in terms of organ function, cardiovascular risk factors, sexual health and socioeconomic aspects. [ Time Frame: 8 years ]
- Rate of intermediate and poor-prognosis disease at relapse. [ Time Frame: 8 years ]
- Rate of offspring spontaneously conceived after testicular cancer treatment. [ Time Frame: 8 years ]
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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|
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 . Metastatic testicular cancers are classified according to the International Germ Cell Cancer Collaborative Group (IGCCCG) risk groups .
- 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.
- Co-existent malignancy within 5 years.
- Inability for any reason to comply with the trial investigations or follow-up schedules.
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
|Kantonsspital St.Gallen; Onkologie/Haematologie||Recruiting|
|St.Gallen, Switzerland, 9007|
|Contact: Christian Rothermundt, Dr. med. +41 71 494 11 11 email@example.com|
|Principal Investigator: Christian Rothermundt, Dr. med.|
|Principal Investigator:||Christian Rothermundt, Dr. med.||Cantonal Hospital of St. Gallen|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Dr. med. Christian Rothermundt, PD Dr. med., Cantonal Hospital of St. Gallen|
|Other Study ID Numbers:||
|First Posted:||September 3, 2014 Key Record Dates|
|Last Update Posted:||August 2, 2021|
|Last Verified:||July 2021|
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Genital Diseases, Male
Male Urogenital Diseases
Endocrine System Diseases