Peripheral Neuropathy, Secondary to Drugs or ChemicalsNCT02661399
Peripheral Blood Biomarkers Associated With CIPN
An observational study of Peripheral Neuropathy, Secondary to Drugs or Chemicals, run by St. Louis University.
Trial summary
The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Secondary to Drugs or Chemicals
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to 10 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have diagnoses which might be treated with CIPN causing therapy, and/or who have CIPN symptoms without potential confounding neuropathies (antecedent diabetic or anatomical peripheral neuropathies).
Who may be able to join
- Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated
- No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN)
- Age ≥ 18 years
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Who cannot join
- Inability to give consent
- Inability to tolerate venipuncture for any reason
- Age < 18 years
- Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician
- Consent Refusal by patient
About this study
Official title: Investigation of Peripheral Blood Biomarkers Associated With CIPN
The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.
Read the detailed description
The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.
- Keywords
- CIPN
- Medical subject headings
- Peripheral Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).
Variant S1P/S1PR related biomarkers; CIPN Questionnaire for Blood Collection Protocol (non-standardized questionnaire, 0-4 rating scales, 0 = no symptoms, 4 = very severe symptoms, symptoms: neuropathic pain severity/unpleasantness, sharpness, depth, tingling, numbness)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startNov 2014
- Primary completion8 May 2017
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy, Secondary to Drugs or ChemicalsStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond C. Tait, PhD, St. Louis University
- Investigators
- Jack Lionberger, MD, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661399
- Sponsor's protocol ID
- 24834
- Status last verified
- Dec 2020
- First submitted
- 19 Jan 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Peripheral Blood Biomarkers Associated With CIPN
- ClinicalTrials.gov ID
- NCT02661399
- Acronym / sponsor ID
- 24834
- Keywords
- CIPN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 22 Jan 2016 (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.
The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.
Detailed description
The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have diagnoses which might be treated with CIPN causing therapy, and/or who have CIPN symptoms without potential confounding neuropathies (antecedent diabetic or anatomical peripheral neuropathies).
Key inclusion criteria (4 listed)
- Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated
- No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN)
- Age ≥ 18 years
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Key exclusion criteria (5 listed)
- Inability to give consent
- Inability to tolerate venipuncture for any reason
- Age < 18 years
- Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician
- Consent Refusal by patient
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
Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).
Time frame: 3 years
Variant S1P/S1PR related biomarkers; CIPN Questionnaire for Blood Collection Protocol (non-standardized questionnaire, 0-4 rating scales, 0 = no symptoms, 4 = very severe symptoms, symptoms: neuropathic pain severity/unpleasantness, sharpness, depth, tingling, numbness)
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 17 Dec 2020.
Related trials for Peripheral Neuropathy, Secondary to Drugs or Chemicals
Not yet recruiting
Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy
Peripheral Neuropathy, Secondary to Drugs or Chemicals, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
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.
Jack Lionberger, MD, PhD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy, Secondary to Drugs or Chemicals, run by St. Louis University.
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 5 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers). (time frame: 3 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 17 Dec 2020.