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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124964
• Other study ID #: CHN-IGCT-002
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: October 30, 2026

Study information

• Verified date: November 2021
• Source: Beijing Tiantan Hospital
• Contact: Bo Li, MD, PhD
• Phone: (86)10-59975581
• Email: libo[@]bjtth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Relapsed disease
• Poor compliance

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Quality of Life

Intervention

Other:
• PedsQL 4.0 Scale
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. PedsQL 4.0 will be evaluated at baseline, yearly through 3 years post-enrollment.
• Short Form-36
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. SF-36 will be evaluated at baseline, yearly through 3 years post-enrollment.
• Chinese Wechsler Intelligence Scale for Children
The intelligence of the child was tested by the China-Wechsler Intelligence Scale for Children (C-WISC), which was revised by Gong and Cai at Hunan Medical University. The C-WISC consists of 11 individual tests that include six verbal tests [Information (I), Comprehend (C), Sorting (S), Arithmetic (A), Vocabulary (V), and Digit symbol (D)] and five performance tests [Picture Completing (PC), Picture Arrangement (PA), Block Pattern (BP), Object Assembly (OA), and Coding (CD)]. Based on individual testing, vocabulary scores (V), procedure scores (P), and full scores (F) were obtained. Furthermore, the VIQ, PIQ, and full intelligence quotient (FIQ) were calculated progressively . C-WISC will be evaluated at baseline, yearly through 3 years post-enrollment.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of score of Chinese Wechsler Intelligence Scale for Children	The intelligence of the child was tested by the China-Wechsler Intelligence Scale for Children (C-WISC), which was revised by Gong and Cai at Hunan Medical University. The C-WISC consists of 11 individual tests that include six verbal tests [Information (I), Comprehend (C), Sorting (S), Arithmetic (A), Vocabulary (V), and Digit symbol (D)] and five performance tests [Picture Completing (PC), Picture Arrangement (PA), Block Pattern (BP), Object Assembly (OA), and Coding (CD)]. Based on individual testing, vocabulary scores (V), procedure scores (P), and full scores (F) were obtained. Furthermore, the VIQ, PIQ, and full intelligence quotient (FIQ) were calculated progressively .	Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.
Primary	Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)	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)	Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.
Secondary	Change of score of the QoL questionnaire (Short form-36)	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)	Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.