Neurotoxicity SyndromesNCT02481336
To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity
An observational study of Neurotoxicity Syndromes, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neurotoxicity Syndromes
- What is being tested?
- Questionnaires, Peripheral nervous system examination and Whole Genome Sequence
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to 31 Dec 2029
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total 300 cancer patients will be enrolled in National Cheng Kung University Hospital from March, 2015 to March, 2017. The subjects are stage I-IV ovarian cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage II-IV endometrial cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage III \& high risk stage II colorectal cancer patients receiving chemotherapy with mFOLFOX.
Who may be able to join
- Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
- Pathological stage I~IV for ovarian cancer, stage II~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer
- Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
- Age ≥ 20 years old
- ECOG Performance status 0-1
- Adequate organ function
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- Bone marrow:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL
- Hepatic:
- Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL
- Renal:
- Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III).
- Negative pregnancy test for women of childbearing potential only
- Patient willing to provide blood sample for research purposes
- Written informed consent
Who cannot join
- Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
- Receiving chemotherapy within 6 months
- History of allergy to 5-FU or LV
- Pre-existing peripheral neuropathy of any grade
- A family history of a genetic or familial neuropathy
- Active uncontrolled infection
- Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (<6 months before enrollment)
- Poor compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
Read the detailed description
This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.
- Conditions
- Neurotoxicity Syndromes
- Being tested
- Questionnaires, Peripheral nervous system examination, Whole Genome Sequence
- Keywords
- Chemotherapy, Peripheral Neuropathy
- Medical subject headings
- Neurotoxicity Syndromes, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
EORTC CIPN20 and EQ-5D-3L
Peripheral nervous system examinationProcedure or surgery
nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)
Whole Genome SequenceGenetic
Genetic Test : 10 mL blood will be collected in Blood Sample Collection
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients receiving chemotherapy | Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage III \& high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX
1. Questionnaires
2. Peripheral nervous system examination
3. Whole Genome Sequence Receives: Other: Questionnaires; Procedure: Peripheral nervous system examination; Genetic: Whole Genome Sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events occurring after chemotherapy based on genomic profiling
Measured: up to 2 years after chemotherapy
Secondary outcomes (7)
Changes in quality-of-life measured by EORTC CIPN20
Measured: up to 2 years after chemotherapy
Changes in quality-of-life measured by EQ-5D-3L
Measured: up to 2 years after chemotherapy
Change from Baseline in nerve conduction velocity (NCV)
Measured: up to 2 years after chemotherapy
Change from Baseline in quantitative sensory test (QST)
Measured: up to 2 years after chemotherapy
Change from Baseline in nerve excitability test (NET)
Measured: up to 2 years after chemotherapy
Relapse-free survival
Measured: up to 5 years after chemotherapy
Overall Survival
Measured: up to 5 years after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotoxicity SyndromesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Ru Shen, PHD, Study chair, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481336
- Sponsor's protocol ID
- A-ER-103-395
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics
- ClinicalTrials.gov ID
- NCT02481336
- Acronym / sponsor ID
- A-ER-103-395
- Conditions
- Neurotoxicity Syndromes
- Keywords
- Chemotherapy, Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jun 2015 (estimated)
- 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.
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
Detailed description
This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients receiving chemotherapy | – | Other: Questionnaires, Procedure: Peripheral nervous system examination, Genetic: Whole Genome SequenceStage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin Stage III \& high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX 1. Questionnaires 2. Peripheral nervous system examination 3. Whole Genome Sequence |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total 300 cancer patients will be enrolled in National Cheng Kung University Hospital from March, 2015 to March, 2017. The subjects are stage I-IV ovarian cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage II-IV endometrial cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage III \& high risk stage II colorectal cancer patients receiving chemotherapy with mFOLFOX.
Key inclusion criteria (15 listed)
- Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
- Pathological stage I~IV for ovarian cancer, stage II~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer
- Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
- Age ≥ 20 years old
- ECOG Performance status 0-1
Key exclusion criteria (8 listed)
- Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
- Receiving chemotherapy within 6 months
- History of allergy to 5-FU or LV
- Pre-existing peripheral neuropathy of any grade
- A family history of a genetic or familial neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesEORTC CIPN20 and EQ-5D-3L | Other | Cancer patients receiving chemotherapy |
| Peripheral nervous system examinationnerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET) | Procedure or surgery | Cancer patients receiving chemotherapy |
| Whole Genome SequenceGenetic Test : 10 mL blood will be collected in Blood Sample Collection | Genetic | Cancer patients receiving chemotherapy |
Primary outcome
Adverse events occurring after chemotherapy based on genomic profiling
Time frame: up to 2 years after chemotherapy
7 secondary outcomes
Changes in quality-of-life measured by EORTC CIPN20
Time frame: up to 2 years after chemotherapy
Changes in quality-of-life measured by EQ-5D-3L
Time frame: up to 2 years after chemotherapy
Change from Baseline in nerve conduction velocity (NCV)
Time frame: up to 2 years after chemotherapy
Change from Baseline in quantitative sensory test (QST)
Time frame: up to 2 years after chemotherapy
Change from Baseline in nerve excitability test (NET)
Time frame: up to 2 years after chemotherapy
Relapse-free survival
Time frame: up to 5 years after chemotherapy
Overall Survival
Time frame: up to 5 years after chemotherapy
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Meng-Ru Shen, PHD study chair
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurotoxicity Syndromes, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 15 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
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?
Adverse events occurring after chemotherapy based on genomic profiling (time frame: up to 2 years after chemotherapy). 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 14 Apr 2026.