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An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy (ASSERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573077
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Europe Ltd

Tracking Information
First Submitted Date October 6, 2015
First Posted Date October 9, 2015
Last Update Posted Date April 4, 2018
Actual Study Start Date October 2015
Actual Primary Completion Date December 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 8, 2015)
  • EQ-5D to measure quality of life [ Time Frame: From baseline up to 6 months ]
    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.
  • EORTC QLQ-C30 to measure quality of life [ Time Frame: From baseline up to 6 months ]
    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.
  • ECOG PS to assess progress of the disease [ Time Frame: From baseline up to 6 months ]
    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.
  • Measure of cognitive impairment: mini-mental state examination (MMSE) [ Time Frame: From baseline up to 6 months ]
    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.
  • 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) ]
    will be used to evaluate rate of readmissions among this population
  • Survival status (%) [ Time Frame: 6 months ]
    Will be used to evaluate overall survival (%) among this population after 6 months.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.
Condition
  • Hyponatremia
  • Syndrome of Inappropriate ADH (SIADH) Secretion
  • Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2018)
69
Original Estimated Enrollment
 (submitted: October 8, 2015)
100
Actual Study Completion Date December 13, 2017
Actual Primary Completion Date December 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age >= 18 years;
  2. Male or female patients with a cytologically or histologically documented cancer diagnosis;
  3. Moderate to severe hyponatremia: Na+ level cut off: [Na+] < 130 mmol/L;
  4. Physician diagnosed Moderate to severe hyponatremia secondary to SIADH (clinical or laboratory determined as per normal routine practice of treating physician);
  5. No use of diuretic agents within the week prior to evaluation;
  6. Willingness to participate in the study; subjects must give their written consent to participate.

Exclusion Criteria:

  1. Use of concomitant medications including demeclocycline and/or urea, by themselves or in combination with fluid restriction;
  2. Subject is currently participating in a clinical trial in which the investigational medicinal product aims to treat the causes or symptoms of hyponatremia;
  3. Life expectancy is lower than 3 months.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02573077
Other Study ID Numbers OPEL/2014/067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Otsuka Pharmaceutical Europe Ltd
Study Sponsor Otsuka Pharmaceutical Europe Ltd
Collaborators Not Provided
Investigators
Study Director: Medical Department Otsuka Europe
PRS Account Otsuka Pharmaceutical Europe Ltd
Verification Date April 2018