Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02492360
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02492360
Study Brief:
Protocol Section:
NCT02492360