An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hypon… (NCT02573077) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Italy69 participantsStarted 2015-10
Plain-language summary
This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum \[Na+\] and the guidelines for the management of this population in Italy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>= 18 years;
. Male or female patients with a cytologically or histologically documented cancer diagnosis;
. Moderate to severe hyponatremia: Na+ level cut off: \[Na+\] \< 130 mmol/L;
. Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician);
. No use of diuretic agents within the week prior to evaluation;
. Willingness to participate in the study; subjects must give their written consent to participate.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction;
. Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia;