Breast CancerNCT04068090
Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer
An observational study of Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Patient Questionnaires and Blood Collection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2019to Dec 2020
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chinese breast cancer patients treated with taxanes
Who may be able to join
- Diagnosis of breast cancer
- Females aged 16 and older
- Planning to receive or previous treated with taxanes
Who cannot join
- Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Hongnan Mo, MD, 8610-87788103, mhnzlyynk@outlook.com
About this study
The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.
- Conditions
- Breast Cancer
- Being tested
- Patient Questionnaires, Blood Collection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient QuestionnairesOther
FACT-Ntx, EORTC-CIPN20
Blood CollectionOther
biomarker analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with CIPN | Patients with peripheral neuropathy after treatment with taxanes Receives: Other: Patient Questionnaires; Other: Blood Collection | |
| Patients without CIPN | Patients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage Receives: Other: Patient Questionnaires; Other: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score from the FACT-GOG-Ntx questionnaire
Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome
Measured: Up to 2 years
Secondary outcomes (2)
Predictive value of genetic variants for the development of neuropathy
SNPs related to peripheral neuropathy
Measured: In the two weeks before start treatment
Total score from the EORTC QLQ - CIPN20 questionnaire
Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Aug 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068090
- Sponsor's protocol ID
- TIPN in China
- Status last verified
- Mar 2020
- First submitted
- 15 Aug 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT04068090
- Acronym / sponsor ID
- TIPN in China
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Aug 2019 (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 purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CIPN | – | Other: Patient Questionnaires, Other: Blood CollectionPatients with peripheral neuropathy after treatment with taxanes |
| Patients without CIPN | – | Other: Patient Questionnaires, Other: Blood CollectionPatients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese breast cancer patients treated with taxanes
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer
- Females aged 16 and older
- Planning to receive or previous treated with taxanes
Key exclusion criteria (1 listed)
- Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity
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 |
|---|---|---|
| Patient QuestionnairesFACT-Ntx, EORTC-CIPN20 | Other | Patients with CIPN, Patients without CIPN |
| Blood Collectionbiomarker analysis | Other | Patients with CIPN, Patients without CIPN |
Primary outcome
Total score from the FACT-GOG-Ntx questionnaire
Time frame: Up to 2 years
Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome
2 secondary outcomes
Predictive value of genetic variants for the development of neuropathy
Time frame: In the two weeks before start treatment
Total score from the EORTC QLQ - CIPN20 questionnaire
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- 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.
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 Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Mar 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongnan Mo, MD (+86-10-87788200, mhnzlyynk@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score from the FACT-GOG-Ntx questionnaire (time frame: Up to 2 years). 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 30 Mar 2020.