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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	11 September 2023
Main ID:	NCT02229916
Date of registration:	27/08/2014
Prospective Registration:	No
Primary sponsor:	Dr. med. Christian Rothermundt
Public title:	Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS SAG TCCS
Scientific title:	Swiss Austrian German Testicular Cancer Cohort Study - SAG TCCS
Date of first enrolment:	December 2013
Target sample size:	6900
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02229916
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Switzerland

Contacts

Name:	Christian Rothermundt, Dr. med.
Address:
Telephone:	+41 71 494 11 11
Email:	christian.rothermundt@kssg.ch
Affiliation:

Name:	Christian Rothermundt, Dr. med.
Address:
Telephone:
Email:
Affiliation:	Cantonal Hospital of St. Gallen

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Testicular Neoplasms

Intervention(s)

Primary Outcome(s)

Mode of relapse detection [Time Frame: 8 years]

Secondary Outcome(s)

Rate of false positive abnormalities on CT scan [Time Frame: 8 years]

Rate of offspring spontaneously conceived after testicular cancer treatment. [Time Frame: 8 years]

Rate of stage I seminoma and non-seminoma patients undergoing active surveillance. [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 intermediate and poor-prognosis disease at relapse. [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 relapses detected on chest x-ray in seminoma patients [Time Frame: 8 years]

Secondary ID(s)

SG359/13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Testicular Cancer Study Group

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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