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:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT04040712
Eligibility Criteria:
Inclusion Criteria:
* 18 years old or older
* treatment with pazopanib or sunitinib for metastatic RCC diagnosed at histology and measurable according to RECIST criteria version 1.1
* development of diarrhea of 2-3 grade according to Common Terminology Criteria (CTC) for Adverse Events (AE) version 4.0 induced by these drugs.
* execution of a CT scan no earlier than 4 weeks before enrollment
* good or intermediate prognostic assessment (according to criteria of the prognostic system of the International Metastatic RCC Database Consortium)
* performance status equal or lower than 2
* blood count, hepatic and kidney testing within normal limit
* ability to give their consent to be included in the study.
Exclusion criteria:
* another known cause of diarrhea (e.g. infectious gastroenteritis. Clostridium difficile infection, celiac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhea)
* previous colorectal surgery or cutaneous stoma
* food allergies
* recent (\<6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antibiotics, probiotics, proton pump inhibitors, immunosuppressants, metformin)
* another cancer (except for surgically treated basocellular carcinoma)
* brain metastases
* decompensated heart failure or heart disease with ejection fraction lower than 30%
* severe respiratory insufficiency
* psychiatric disorders
* pregnancy
* unable to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04040712
Study Brief:
Protocol Section:
NCT04040712