HyponatremiaASSERTNCT02573077
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
An observational study of Hyponatremia and Syndrome of Inappropriate ADH (SIADH) Secretion, run by Otsuka Pharmaceutical Europe Ltd at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion, Cancer
- How many people
- 69 participants
- Where
- 20 sitesItaly
- Study dates
- Oct 2015to 13 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Study site
Ancona
Study site
Aosta
Study site
Bari
Study site
Cagliari
Study site
Cosenza
Study site
Florence
Study site
Genova
Study site
Messina
Study site
Milan
Study site
Naples
Study site
Negrar
Study site
Novara
Study site
Palermo
Study site
Parma
Study site
Perugia
Study site
Piacenza
Study site
Pisa
Study site
Roma
Study site
Varese
Study site
Verona
About this study
Official title: A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy
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.
- Keywords
- Hyponatremia due to SIADH, Cancer
- Medical subject headings
- Hyponatremia, Inappropriate ADH Syndrome, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month and 6 months
Secondary outcomes (8)
EQ-5D to measure quality of life
Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
EQ-5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Measured: From baseline up to 6 months
EORTC QLQ-C30 to measure quality of life
Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
EORTC QLC-C30: European Organisation for Research and Treatment of Cancer (EORTC) Study Group on Quality of Life has developed the EORTC QLQ-C30 questionnaire consisting in a modular system for assessing the quality of life of cancer patients in clinical research.
Measured: From baseline up to 6 months
ECOG PS to assess progress of the disease
Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
The Eastern Cooperative Oncology Group (ECOG) performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate (oncology) treatment and prognosis.
Measured: From baseline up to 6 months
Measure of cognitive impairment: mini-mental state examination (MMSE)
Will be assessed at baseline and at subsequent visits (falling within routine clinical practice) until 6 months.
The mini-mental state examination (MMSE) or Folstein test is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.
Measured: From baseline up to 6 months
Time to chemotherapy (days)
Measured: Longitudinal (up to 6 months)
Length of stay (days)
Measured: Longitudinal (up to 6 months)
Readmission (number of readmissions)
will be used to evaluate rate of readmissions among this population
Measured: Longitudinal (up to 6 months)
Survival status (%)
Will be used to evaluate overall survival (%) among this population after 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Europe Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Department, Study director, Otsuka Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573077
- Sponsor's protocol ID
- OPEL/2014/067
- Acronym
- ASSERT
- Status last verified
- Apr 2018
- First submitted
- 6 Oct 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia Secondary to SIADH in Italy
- ClinicalTrials.gov ID
- NCT02573077
- Acronym / sponsor ID
- ASSERT / OPEL/2014/067
- Keywords
- Hyponatremia due to SIADH, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum [Na+]
Time frame: 1 month and 6 months
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
8 secondary outcomes
EQ-5D to measure quality of life
Time frame: From baseline up to 6 months
EORTC QLQ-C30 to measure quality of life
Time frame: From baseline up to 6 months
ECOG PS to assess progress of the disease
Time frame: From baseline up to 6 months
Measure of cognitive impairment: mini-mental state examination (MMSE)
Time frame: From baseline up to 6 months
Time to chemotherapy (days)
Time frame: Longitudinal (up to 6 months)
Length of stay (days)
Time frame: Longitudinal (up to 6 months)
Readmission (number of readmissions)
Time frame: Longitudinal (up to 6 months)
Survival status (%)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Department study director
Otsuka Europe
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Syndrome of Inappropriate ADH (SIADH) Secretion, run by Otsuka Pharmaceutical Europe Ltd at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum [Na+] (time frame: 1 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.