Pediatric CancerNCT07053579
Cross-cultural Adaptation and Validation of the P-CIN for Chinese Pediatric Oncology Patients
An observational study of Pediatric Cancer, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial summary
The goal of this study was to conduct a cross-cultural adaptation of the P-CIN into the Chinese context, assess its psychometric properties, and determine the cut-off value of CIPN among Chinese pediatric oncology patients. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Cancer
- How many people
- 313 participants
- Where
- 2 sitesHong Kong
- Study dates
- 5 Jan 2025to 30 May 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We recruited pediatric oncology patients from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.
Who may be able to join
- (1) 6 to 18 years of age
- (2) were diagnosed with cancer
- (3) had received or were currently receiving neurotoxic chemotherapy drugs (e.g., Vincristine, Cisplatin, Carboplatin, Oxaliplatin, Paclitaxel, Docetaxel, Ixabepilone, Bortezomib, Thalidomide)
- (4) were able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure they understood the P-CIN.
Who cannot join
- (1) had a diagnosis of cancer in the central nervous system (CNS) cancer, cancer relapse or secondary cancer
- (2) in the terminal stage
- (3) planned to receive multiple cancer treatment (e.g., radiotherapy and immunotherapy)
- (4) suffered from other neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy)
- (5) had a developmental deficit (e.g., Down's syndrome and other chromosomal disorders)
- (6) have suffered from psychiatric diseases or used antipsychotic drugs
- (7) had peripheral neuropathy symptoms caused by diabetes, genetic diseases, spinal cord injury, or alcoholism, or
- (8) had other neuromuscular disorders (e.g., traumatic brain injury, cerebral palsy).
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Ka Yan Ho
Hong Kong, China
The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Cross-cultural Adaptation and Validation of the Pediatric Chemotherapy-induced Neuropathy (P-CIN) for Chinese Pediatric Oncology Patients: A Multi-center Study
The goal of this study was to conduct a cross-cultural adaptation of the P-CIN into the Chinese context, assess its psychometric properties, and determine the cut-off value of CIPN among Chinese pediatric oncology patients.
Participants provided demographic and clinical characteristics, and complete the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life.
Read the detailed description
A methodological, descriptive study was conducted.
- Conditions
- Pediatric Cancer
- Keywords
- Chemotherapy induced peripheral neuropathy, Pediatric Chemotherapy-Induced Neuropathy, Pediatric oncology, Psychometrics, Validation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Participants completed the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale
For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start5 Jan 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 313 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Shenzhen Children's Hospital, Zhengzhou University
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053579
- Sponsor's protocol ID
- Validation study_P-CIN
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of the Pediatric Chemotherapy-induced Neuropathy (P-CIN) for Chinese Pediatric Oncology Patients: A Multi-center Study
- ClinicalTrials.gov ID
- NCT07053579
- Acronym / sponsor ID
- Validation study_P-CIN
- Conditions
- Pediatric Cancer
- Keywords
- Chemotherapy induced peripheral neuropathy, Pediatric Chemotherapy-Induced Neuropathy, Pediatric oncology, Psychometrics, Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Shenzhen Children's Hospital, Zhengzhou University
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study was to conduct a cross-cultural adaptation of the P-CIN into the Chinese context, assess its psychometric properties, and determine the cut-off value of CIPN among Chinese pediatric oncology patients.
Participants provided demographic and clinical characteristics, and complete the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life.
Detailed description
A methodological, descriptive study was conducted.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | –Participants completed the translated P-CIN, Wong-baker FACES Pain Rating scale for pain, and Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module for quality of life. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We recruited pediatric oncology patients from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.
Key inclusion criteria (4 listed)
- (1) 6 to 18 years of age
- (2) were diagnosed with cancer
- (3) had received or were currently receiving neurotoxic chemotherapy drugs (e.g., Vincristine, Cisplatin, Carboplatin, Oxaliplatin, Paclitaxel, Docetaxel, Ixabepilone, Bortezomib, Thalidomide)
- (4) were able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure they understood the P-CIN.
Key exclusion criteria (8 listed)
- (1) had a diagnosis of cancer in the central nervous system (CNS) cancer, cancer relapse or secondary cancer
- (2) in the terminal stage
- (3) planned to receive multiple cancer treatment (e.g., radiotherapy and immunotherapy)
- (4) suffered from other neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy)
- (5) had a developmental deficit (e.g., Down's syndrome and other chromosomal disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale
Time frame: Baseline
For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Yan Ho, PhD principal investigator
The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.