Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorDr. med. Christian Rothermundt

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Co-existent malignancy within 5 years.

Inability for any reason to comply with the trial investigations or follow-up schedules.

Trial 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 \[47\].

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
8 years

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. med. Christian Rothermundt

Lead sponsor

Cantonal Hospital of St. Gallen

Sponsor institution

German Testicular Cancer Study Group

Collaborator