An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
ASSERT
A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy
1 other identifier
observational
69
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 6, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2017
CompletedApril 4, 2018
April 1, 2018
2.2 years
October 6, 2015
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum [Na+]
Change in serum \[Na+\] from the baseline visit to the end of the first month or sixth month of the observational period or until earlier discontinuation from the study
1 month and 6 months
Secondary Outcomes (8)
EQ-5D to measure quality of life
From baseline up to 6 months
EORTC QLQ-C30 to measure quality of life
From baseline up to 6 months
ECOG PS to assess progress of the disease
From baseline up to 6 months
Measure of cognitive impairment: mini-mental state examination (MMSE)
From baseline up to 6 months
Time to chemotherapy (days)
Longitudinal (up to 6 months)
- +3 more secondary outcomes
Eligibility Criteria
This non-interventional study will include cancer patients who need a treatment for hyponatremia secondary to SIADH in one of the hospitals participating in the study.
You may qualify if:
- 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.
You may not qualify if:
- 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;
- Life expectancy is lower than 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Ancona, Italy
Unknown Facility
Aosta, Italy
Unknown Facility
Bari, Italy
Unknown Facility
Cagliari, Italy
Unknown Facility
Cosenza, Italy
Unknown Facility
Florence, Italy
Unknown Facility
Genova, Italy
Unknown Facility
Messina, Italy
Unknown Facility
Milan, Italy
Unknown Facility
Napoli, Italy
Unknown Facility
Negrar, Italy
Unknown Facility
Novara, Italy
Unknown Facility
Palermo, Italy
Unknown Facility
Parma, Italy
Unknown Facility
Perugia, Italy
Unknown Facility
Piacenza, Italy
Unknown Facility
Pisa, Italy
Unknown Facility
Roma, Italy
Unknown Facility
Varese, Italy
Unknown Facility
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Department
Otsuka Europe
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2015
First Posted
October 9, 2015
Study Start
October 1, 2015
Primary Completion
December 13, 2017
Study Completion
December 13, 2017
Last Updated
April 4, 2018
Record last verified: 2018-04