Prospective multicenter trail to evaluate the quality of life of patients with clinical stage I germ cell cancer. Does the therapy modality influence the quality of life of the patients in the course of the disease?

Recruiting

• Conditions: C62; C62.0; C62.1; C62.9; Malignant neoplasm of testis; Undescended testis; Descended testis; Testis, unspecified

• Registration Number: DRKS00020991
• Lead Sponsor: Bundeswehrzentralkrankenhaus Koblenz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

Seminoma or Nonseminoma clinical stage I
- normalization of tumor markers after surgery
- age >18 years
- male
- WHO Performance Status 0-2

Exclusion Criteria

- NSGCT CSI with marker Elevation after Ablatio testis
- known malign tumor disease in the last 5 years before study recruitment
- known infection with HIV, Hepatitis B or Hepatitis C
- known severe disease or an uncontrolled desease, or active infection
- psychological disease
- female or Intersexual
- age <18 Jahre
- WHO-Performance-Status 3-4

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life evaluated with the questionnaires: EORTC QLQ-C30 and QLQ-TC26.<br><br>Longitudinal presentation of quality of life of testicular cancer patients in clinical stage I, 5 years after initial therapy, influence of different therapies on development of quality of life.

Secondary Outcome Measures

Name	Time	Method
Type and duration of surgery, complications of surgery, early and late toxicities, duration of Hospital stay, duration of sick leave <br>Identification of demographic and socioeconomical variables which might go along with a deterioration of qol like: level of education, work status, social status, family situation. <br>Do risk profiles exist which go along with a reduced QoL?<br>Evaluation of QoL in recruiting clinics <br>Evaluation of different dimensions of QoL during different timelines. <br>Evaluation of hormonal status and an potential infertility during therapy <br>Problems with sexuality during therapy <br>Use of psychoncological assistance