Biomarkers of epithelial tissue injury in dogs and cats receiving cytotoxic therapy

Purpose and Brief Study Description:

Cytotoxic therapy can be non-specific to the cancer cells and may result in significant normal tissue complications. The aim of current therapeutic protocols is to target tumor cells and spare normal tissues, but each patient with different genetic background or health condition may respond to the therapeutics differently. There is currently a need for practical tools for early detection and monitoring of normal tissue injury. There are several keratin 18 (K18) based markers which detect total soluble K18 released from dead cells (necrotic and apoptotic) of epithelial origin (kidney, GI, lung and liver). We propose to evaluate the usability of K18 markers to detect and monitor epithelial tissue damage in dogs and cats undergoing cytotoxic therapy for their malignancy.

Enrollment Criteria:

Eligibility: Dogs and cats with a malignancy:

• Dogs and cats undergoing cytotoxic therapy for a malignancy where normal epithelial cells are exposed to possible damage. This may include treatment with toceranib phosphate, radiation therapy, and chemotherapeutic agents.
• Dogs and cats must be deemed otherwise healthy by a study clinician prior to study entry.

Eligibility: Dogs and cats with no malignancy (healthy control patients):

• Must be deemed healthy by a study clinician prior to entry.
• Must not have any evidence of GI distress or other signs of epithelial tissue damage.

What does enrollment into this trial involve?

For patients with a malignancy,2 to 5mL of blood will be collected before, and at least one time after cytotoxic therapy. This will be dependent upon the treatment regimen prescribed by the attending Oncologist. Post-treatment blood collections will occur at recheck visits to the VHC (up to 5 collections total) and will usually be 1 to 4 weeks after treatment. If a patient experiences epithelial side effects, the interval of blood sampling may be reduced.

For control patients (healthy dogs and cats with no malignancy,) 2 to 5mL of blood will be collected one time only.

Client Compensation:

There is no cost or reimbursement for you to participate in this study.

Contact Information:

For more information about this trial, please contact Kris Richardson, Clinical Trials Coordinator:

Phone: (785)-532-3046, email: ClinicalTrials@vet.k-state.edu