Clinical Trials
Patient data acquisition and analysis approaches maximizing search for biomarkers considering clinical diagnostic diversity and genetic and epigenetic influence (CTMS# 22-0069)
Cancer Type
Breast
ClinicalTrials.gov Identifier
ClinicalTrials.gov registration not required
Principal Investigator
Virginia Kaklamani MD
For more information about this study
View DetailsAbout This Study
This is a translational clinical study aiming to develop approaches to process effectively human tissues and identify biomarkers for painful and non-painful chemotherapy-induced peripheral neuropathy (CIPN). This study will involve obtaining two skin biopsies representing affected and non-affected parts of each patient’s limb. Painful and non-painful neuropathies will be determined by a variety of standard approaches implemented by a neurologist Dr. Bhavaraju-Sanka.
What is the criteria to participate?
Note: This is only a partial list of eligibility criteria.
Inclusion Criteria:
Inclusion criteria
- Histologically confirmed diagnosis of early-stage breast cancer (stage I-III).
- Has received adjuvant or neo-adjuvant taxane-based chemotherapy within 10-30 days of consent
- Age > 18 years. There is no upper age limit for participation in this study.
- Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation.
- Prior chemotherapies for previous cancers are permitted, except with prior treatments with taxane, vinca alkaloids, gemcitabine, Eribulin, ixabepilone)5
- All patients will have given signed, informed consent prior to registration
- Patients must have a performance status of ECOG 0 or 1.
Exclusion Criteria:
Exclusion Criteria
- Patients must not have a personal history of peripheral neuropathy (regardless of cause) or chronic pain (such as fibromyalgia) prior to receiving taxane chemotherapy
- Patient must not have a history of diabetes mellitus.
- Patient must not have a history of Raynaud’s disease.
- Patients must not be receiving Gabapentin or Pregabalin at time of consent
- Patients with partial or complete limb amputations.
- As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness, or social condition that would limit compliance with study requirements.