Prospective Study on Quality of Life in Patients With Intracranial Germ Cell Tumors

Recruiting

• Conditions: Quality of Life
• Interventions: Other: PedsQL 4.0 Scale; Other: Short Form-36; Other: Chinese Wechsler Intelligence Scale for Children

• Registration Number: NCT05124964
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

The primary purpose of this study is to characterize the quality of life in patients with intracranial germ cell tumors. Those findings can contribute towards a better understanding of the impact of the current treatment strategy on survivors.

Detailed Description

The characteristics of the quality of life in patients with intracranial germ cell tumors are far from understood. The main reason is the rare occurrence of the disease. As a result, most findings came from retrospective studies in which only dozens of patients participated. Generally, patients with intracranial germ cell tumors have a good prognosis, especially those with germinoma.

Over 90% of patients with germinoma will survival after ten years of follow-up. Thus, the quality of life in long-term survivors is of concern. The investigators designed this prospective study to address this issue to understand better the characteristics of the quality of life in patients with intracranial germ cell tumors and provide information for optimizing the current treatment strategy.

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2021-10-13
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-07
• Last Update Submitted: 2021-11-07
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 3 years ≤ age ≤ 21 years
• Newly diagnosed primary intracranial germ cell tumors
• Written informed consent

Exclusion Criteria

• Relapsed disease
• Poor compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	PedsQL 4.0 Scale	Patients with newly diagnosed primary intracranial germ cell tumors are scheduled for subsequent anti-tumor therapy.
1	Short Form-36	Patients with newly diagnosed primary intracranial germ cell tumors are scheduled for subsequent anti-tumor therapy.
1	Chinese Wechsler Intelligence Scale for Children	Patients with newly diagnosed primary intracranial germ cell tumors are scheduled for subsequent anti-tumor therapy.

Primary Outcome Measures

Name	Time	Method
Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)	Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.	The PedsQL 4.0 Generic Core Scale contains 23 items that measures physical (eight items), emotional (five items), social (five items), and school (five items) functions. The Scale comprises parallel patient self-report and parent proxy-report formats. The items are reverse-scored and trans- formed to a 0-100 scale according to the instructions, and higher scores indicate a better HRQOL. (age ≤18 years)

Secondary Outcome Measures

Name	Time	Method
Change of score of the QoL questionnaire (Short form-36)	Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.	Altogether, 36 questions with standardized response choices were organized into eight scales, including physical functioning (PF), role limitations as a result of physical health problems (RP), body pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations as a result of emotional problems (RE), and general mental health (MH). Additionally, reported health transition (HT) was used to evaluate general health changes during the previous year. The raw scores were converted to a 0-100 scale according to the instructions, and higher scores indicated a better HRQOL. Physical component score (PCS) and mental component score (MCS) were also calculated. (Age \>15 years)

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China