Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy

Primary Objective-To establish a biobank of specimens that allows for the future creation of
iPS cells with the potential to make human neurons for functional studies of specific
genes/genetic variants.

Secondary Objectives-To develop a clinically relevant in vitro model of cisplatin induced
peripheral neuropathy to be used to 1) screen new drugs for the treatment or prevention of
peripheral neuropathy; 2) evaluate candidate genes for their role in cisplatin induced
neuropathy.

Study Procedures-Subjects who wish to participate will undergo the following study
procedures, which will be performed after the informed consent document is obtained:

1. Sample Collection-A trained phlebotomist will conduct a blood draw for the collection
of SIX samples for peripheral blood mononuclear cell (PBMC) isolation and infectious
disease testing.

2. Patient Self-Report of Toxicities-All patients in the study will be asked to fill out
the Patient-reported Toxicity Form. This will take approximately 10 minutes to complete
and consists of 20 questions related to patient symptoms describing toxicities
experienced secondary to receiving cisplatin chemotherapy. They will be asked to fill
out the form twice: (1) describing the peripheral neuropathy they currently are
experiencing and (2) describing the worst peripheral neuropathy toxicity they
experienced as a result of cisplatin therapy. These paper forms will be filled out at
time of enrollment in the study.

3. Physician Report of Toxicities-The patient's physician or the designatee will complete
an adverse event form at day of enrollment detailing the physician's assigned grade of
toxicities (according to CTCAE version 4.3) experienced from cisplatin. Other
information regarding the particularly severe neurotoxicity may also be collected from
physicians (e.g. patient use of walker or wheelchair, patient application for
disability based on neuropathy).

4. General Information- This information will be collected at the same time point as all
of the other study procedures (i.e., Day One). This will include but may not be limited
to: age, height, weight, patient-identified race and ethnicity, information about the
chemotherapy regimen, total cisplatin dose administered and date of last cisplatin
dose.

5. Cisplatin Dose-Total cumulative dose of cisplatin administered will be recorded.
Outside records will be obtained where needed.

6. Follow-up and Duration of Follow-Up-There will be no subsequent patient follow-up after
time of enrollment. Subjects may withdraw consent for specimen use by contacting the PI
in writing.

Inclusion Criteria---Severe Toxicity Group

1. Diagnosis of testicular cancer

2. Age ≥ 18 years at the time of informed consent

3. Male

4. History of any grade 3 or higher peripheral neuropathy after receiving standard dose
cisplatin completed more than 1 year but within the last 5 years

5. Long-term persistence (> 6 months) of grade 2 or higher peripheral neuropathy after
completion of a cisplatin containing regimen.

6. Patient understands the nature of the study and provides written informed consent

Inclusion Criteria---Control Group

1. Diagnosis of testicular cancer

2. Age ≥ 18 years

3. Male

4. No history of neurotoxicity (grade 0-1) after completion of a standard
cisplatin-containing chemotherapy regimen completed more than 1 year but within the
last 5 years

5. Matched to a specified subject with neurotoxicity based on age (within 10 years),
chemotherapy regimen or total cisplatin dosage

6. Patient understands the nature of the study and provides informed consent

Exclusion Criteria (Both groups)

1. Treatment with other severely neurotoxic chemotherapy prior to or concomitantly with
cisplatin.

2. Presence of peripheral neuropathy prior to cisplatin therapy

3. Poorly controlled or insulin-dependent diabetes or other conditions likely to
predispose neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)