Patient data acquisition and analysis approaches maximizing search for biomarkers considering clinical diagnostic diversity and genetic and epigenetic influence
Lay Description
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.
Category
- Cancers and Other Neoplasms
- Diagnostic
- Genetics
- Breast
- IRB Number
- 20220482HU
- NCT Number
- NCT # not yet entered
Eligibility
- Eligible Ages
- 18 and over
- Eligible Genders
- All
- Accepts Healthy Volunteers
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
- 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.
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Principal Investigator
Virginia Kaklamani