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NCT Number: NCT05124964

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

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.

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Key information

Conditions

Age range

3 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Relapsed disease
  • Poor compliance

Treatment and study plan

PedsQL 4.0 Scale

Other

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.

Other names: PedsQL 4.0 Generic Core Scale

Short Form-36

Other

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.

Other names: SF-36

Chinese Wechsler Intelligence Scale for Children

Other

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.

Other names: C-WISC

Primary outcomes

  1. Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)

    Time frame: 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 outcomes

  1. Change of score of the QoL questionnaire (Short form-36)

    Time frame: 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)

Other outcomes

  1. Change of score of Chinese Wechsler Intelligence Scale for Children

    Time frame: Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.

    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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Li, MD, PhD

CONTACT

[email protected]

(86)10-59975581

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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