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

NCT05124964 | Recruiting

• 1 other identifier: CHN-IGCT-002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

intracranial germ cell tumors; quality of life

Outcome Measures

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)

  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 Outcomes (1)

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

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

Other Outcomes (1)

• Change of score of Chinese Wechsler Intelligence Scale for Children

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

Study Arms (1)

1

Patients with newly diagnosed primary intracranial germ cell tumors are scheduled for subsequent anti-tumor therapy.

Other: PedsQL 4.0 Scale; Other: Short Form-36; Other: Chinese Wechsler Intelligence Scale for Children

Interventions

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.

Also known as: PedsQL 4.0 Generic Core Scale

1

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.

Also known as: SF-36

1

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.

Also known as: C-WISC

1

Eligibility Criteria

• Age: 3 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed primary intracranial germ cell tumors are eligible for the study, including those diagnosed based on serum/cerebral spinal fluid tumor marker(s) elevation (β-HCG and/or AFP) and/or pathology.

You may qualify if:

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

You may not qualify if:

• Relapsed disease
• Poor compliance

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

RECRUITING

Study Officials

• Tao Jiang, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Li, MD, PhD

CONTACT

(86)10-59975581; libo@bjtth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 18, 2021
• Study Start: October 12, 2021
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

CN (1)