Myelodysplastic SyndromesNCT00967564
Survey on QUality of Life In myeloDisplasia (SQUID)
An observational study of Myelodysplastic Syndromes, run by Janssen-Cilag S.p.A..
Trial summary
The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- epidemiologic study
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Nov 2009
- 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: outpatients
Who may be able to join
- Primary or secondary MDS
- At least one cytopenia according to International Prognostic Score System (IPSS) criteria (Hb < 10 g/dL
- Absolute neutrophils count (a type of white cell that fights against infection) < 1.800/µL
- platelets (irregularly shaped cells found in blood that help prevent bleeding) < 100.000/µL)
- Willing and able, based on investigator's judgment, to fill in QoL questionnaires
Who cannot join
- Refractory anemia with excess blasts (tumor cells located in the marrow > 20%)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) >3
- History of cerebrovascular disease with cognitive outcomes
- Psychiatric diseases or senile or vascular dementia
- Positive anamnesis for another clinically active tumor or when treatment has been stopped since less than 5 years
About this study
Official title: QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME
The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation
Read the detailed description
In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia has been associated with increased cardiac disease which, in older patients, may aggravate pre-existing conditions such as congestive heart failure. Patients with MDS often require red blood cell transfusions that further deteriorate patients' perception of well-being. This is an 18-month prospective observational investigation about the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of white blood cells that fights against infection) or low level of platelets (irregularly shaped cells found in blood that help prevent bleeding) - will be included in the evaluation. Demographic and disease-specific data will be collected and QoL will be evaluated by a specific questionnaire named QoL-E which will be completed both by patients and respective physicians. Study visits will be performed monthly until week 12; the subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be collected during the study, only adverse reaction to any Janssen-Cilag drug should be reported. This information may be important to optimize treatment according to patients' preferences and expectations, to detect functional complications, as well as to improve communication between patients and caregivers. Observational study - No study drug was administered.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- epidemiologic study
- Keywords
- Myelodysplastic Syndrome, Quality of Life, Anemia, Epoetin alfa, Eprex
- Medical subject headings
- Myelodysplastic Syndromes, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiologic studyOther
QoL assessment
| Study group | Role | What they receive |
|---|---|---|
| 001 | epidemiologic study QoL assessment Receives: Other: epidemiologic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between quality of life and hemoglobin in patients with new diagnosis of myelodysplastic syndrome
Measured: At baseline, at week 12, and at months 12 and 18
Secondary outcomes (2)
Correlation between Hb changes and QoL changes
Measured: At baseline, at week 12, and at months 12 and 18 of observation
Comparison between the patient's and physician's QoL perception
Measured: At baseline, at week 12, and at months 12 and 18 of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startMar 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A. Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967564
- Sponsor's protocol ID
- CR013075
- Status last verified
- Apr 2014
- First submitted
- 27 Aug 2009
- Last updated
- 28 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME
- ClinicalTrials.gov ID
- NCT00967564
- Acronym / sponsor ID
- CR013075
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Myelodysplastic Syndrome, Quality of Life, Anemia, Epoetin alfa, Eprex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Aug 2009 (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.
The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation
Detailed description
In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia has been associated with increased cardiac disease which, in older patients, may aggravate pre-existing conditions such as congestive heart failure. Patients with MDS often require red blood cell transfusions that further deteriorate patients' perception of well-being. This is an 18-month prospective observational investigation about the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of white blood cells that fights against infection) or low level of platelets (irregularly shaped cells found in blood that help prevent bleeding) - will be included in the evaluation. Demographic and disease-specific data will be collected and QoL will be evaluated by a specific questionnaire named QoL-E which will be completed both by patients and respective physicians. Study visits will be performed monthly until week 12; the subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be collected during the study, only adverse reaction to any Janssen-Cilag drug should be reported. This information may be important to optimize treatment according to patients' preferences and expectations, to detect functional complications, as well as to improve communication between patients and caregivers. Observational study - No study drug was administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: epidemiologic studyepidemiologic study QoL assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients
Key inclusion criteria (5 listed)
- Primary or secondary MDS
- At least one cytopenia according to International Prognostic Score System (IPSS) criteria (Hb < 10 g/dL
- Absolute neutrophils count (a type of white cell that fights against infection) < 1.800/µL
- platelets (irregularly shaped cells found in blood that help prevent bleeding) < 100.000/µL)
- Willing and able, based on investigator's judgment, to fill in QoL questionnaires
Key exclusion criteria (5 listed)
- Refractory anemia with excess blasts (tumor cells located in the marrow > 20%)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) >3
- History of cerebrovascular disease with cognitive outcomes
- Psychiatric diseases or senile or vascular dementia
- Positive anamnesis for another clinically active tumor or when treatment has been stopped since less than 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidemiologic studyQoL assessment | Other | 001 |
Primary outcome
Correlation between quality of life and hemoglobin in patients with new diagnosis of myelodysplastic syndrome
Time frame: At baseline, at week 12, and at months 12 and 18
2 secondary outcomes
Correlation between Hb changes and QoL changes
Time frame: At baseline, at week 12, and at months 12 and 18 of observation
Comparison between the patient's and physician's QoL perception
Time frame: At baseline, at week 12, and at months 12 and 18 of observation
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 28 Apr 2014.
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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.
Janssen-Cilag S.p.A. Clinical Trial study director
Janssen-Cilag S.p.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Janssen-Cilag S.p.A..
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 5 inclusion and 5 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between quality of life and hemoglobin in patients with new diagnosis of myelodysplastic syndrome (time frame: At baseline, at week 12, and at months 12 and 18). 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 28 Apr 2014.