Acute Lymphoblastic Leukemia ALLNCT07326930
Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia ALL, run by The Hong Kong Polytechnic University at 3 sites in China.
Trial summary
The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia ALL
- How many people
- 173 participants
- Where
- 3 sitesChina
- Study dates
- 2 Jun 2025to 7 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with acute lymphoblastic leukemia are recruited from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.
Who may be able to join
- diagnosed with acute lymphoblastic leukemia
- aged from 8 to 17 years
- will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)
- conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately
- written informed assent is obtained from the children and their parents for their participation in the study
Who cannot join
- participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms.
- with severe complications, including but not limited to significant heart, brain, or lung function failure.
- had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury.
- had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy).
- had central nervous system cancer or secondary cancer.
- had multiple treatment like radiotherapy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai
Nanping Shen, +86 380886336, yb@scmc.com.cn
Ping Nan Shen
- Recruiting
Shenzhen Children's Hospital
Shenzhen
Haixia Wang, +86 83936101, szchildcvc@163.com
Xia Hai Wang
- Recruiting
The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital,
Zhengzhou, Henan
Funa Yang, +86 65587320, hnszlyyyb@163.com
Na Fu Yang
About this study
Official title: Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study
The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Keywords
- Chemotherapy induced peripheral neuropathy, tracjectory, predictor, children, acute lymphoblastic leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 will complete chemotherapy induced peripheral neuropathy, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy scales. |
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: One week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4(T5), two weeks after T5(T6), two weeks after T6(T7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start2 Jun 2025
- Primary completion7 Jan 2026 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia ALLStudies 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
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326930
- Sponsor's protocol ID
- CIPN trajectories
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study
- ClinicalTrials.gov ID
- NCT07326930
- Acronym / sponsor ID
- CIPN trajectories
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Keywords
- Chemotherapy induced peripheral neuropathy, tracjectory, predictor, children, acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 7 Jan 2026 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 8 Jan 2026 (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 is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | –Participants will complete chemotherapy induced peripheral neuropathy, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy scales. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with acute lymphoblastic leukemia are recruited from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.
Key inclusion criteria (5 listed)
- diagnosed with acute lymphoblastic leukemia
- aged from 8 to 17 years
- will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)
- conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately
- written informed assent is obtained from the children and their parents for their participation in the study
Key exclusion criteria (6 listed)
- participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms.
- with severe complications, including but not limited to significant heart, brain, or lung function failure.
- had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury.
- had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy).
- had central nervous system cancer or secondary cancer.
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: One week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4(T5), two weeks after T5(T6), two weeks after T6(T7)
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- 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.
Ka Yan Ho principal investigator
The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia ALL, run by The Hong Kong Polytechnic University at 3 sites in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Yan Ho, PhD (852-27666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale (time frame: One week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4(T5), two weeks after T5(T6), two weeks after T6(T7)). 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 Jan 2026.