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, DSc

For more information about this study
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About 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.