CML (Chronic Myelogenous Leukemia)Case-OnlyNCT05092048
A Study for PRO of CML in Real Word
An observational study of CML (Chronic Myelogenous Leukemia), run by xuna at 1 site in China.
Trial summary
Successful outcomes in CML require both prolonged adherence to oral TKI therapy by patients and careful monitoring of treatment responses by their physicians. Patient Reported Outcomes(PRO) assessment is important to facilitate decisions in the current treatment landscape of CML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML (Chronic Myelogenous Leukemia)
- What is being tested?
- questionnaire
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2021to 1 Oct 2022
- How long will I take part?
- 1 Year
- 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: Above 18 years of age. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Nanfang Hospital, Southern Medical University,
Guanzhou
Department of Hematology Nanfang Hospital Southern M University, 02062787883, 292347668@qq.com
About this study
Official title: Validation Value of the Questionnaire to Assess Health-related Quality of Life in Patients With CML
Successful outcomes in CML require both prolonged adherence to oral TKI therapy by patients and careful monitoring of treatment responses by their physicians. Patient Reported Outcomes(PRO) assessment is important to facilitate decisions in the current treatment landscape of CML.
Read the detailed description
- Above 18 years of age.
- Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
- Written informed consent.
- Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.
- Conditions
- CML (Chronic Myelogenous Leukemia)
- Being tested
- questionnaire
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
PHQ-9 and GAD-7 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| CML patient | ≥18 years old CML patiente Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia
Health-related quality of life (HRQOL) assessment in the current treatment landscape of chronic myeloid leukemia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start22 Sep 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CML (Chronic Myelogenous Leukemia)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- xuna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xuna, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092048
- Sponsor's protocol ID
- CML0922
- Acronym
- Case-Only
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
Publications
Chen H, Wen Y, Zeng Y, Lin L, Sun B, Zhu H, He H, Wang X, Zou W, Zheng C, Zheng L, Huang J, Pang L, Huang J, Zhang Y, Lin H, Liu Z, Zhu W, Wang Q, Zhou X, Liu X, Qu H, Liu Z, Du X, Xu N. Patient Versus Physician Perspective in the Management of Chronic Myeloid Leukemia During Treatment with Tyrosine Kinase Inhibitors. Oncol Ther. 2024 Mar;12(1):131-145. doi: 10.1007/s40487-023-00255-2. Epub 2023 Dec 16.
PubMed 38104036
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Value of the Questionnaire to Assess Health-related Quality of Life in Patients With CML
- ClinicalTrials.gov ID
- NCT05092048
- Acronym / sponsor ID
- Case-Only / CML0922
- Conditions
- CML (Chronic Myelogenous Leukemia)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- xunaUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- 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.
Successful outcomes in CML require both prolonged adherence to oral TKI therapy by patients and careful monitoring of treatment responses by their physicians. Patient Reported Outcomes(PRO) assessment is important to facilitate decisions in the current treatment landscape of CML.
Detailed description
- Above 18 years of age.
- Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
- Written informed consent.
- Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML patient | – | Other: questionnaire≥18 years old CML patiente |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Above 18 years of age. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
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 |
|---|---|---|
| questionnairePHQ-9 and GAD-7 questionnaire | Other | CML patient |
Primary outcome
Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia
Time frame: 1 year
Health-related quality of life (HRQOL) assessment in the current treatment landscape of chronic myeloid leukemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 38104036Chen H, Wen Y, Zeng Y, Lin L, Sun B, Zhu H, He H, Wang X, Zou W, Zheng C, Zheng L, Huang J, Pang L, Huang J, Zhang Y, Lin H, Liu Z, Zhu W, Wang Q, Zhou X, Liu X, Qu H, Liu Z, Du X, Xu N. Patient Versus Physician Perspective in the Management of Chronic Myeloid Leukemia During Treatment with Tyrosine Kinase Inhibitors. Oncol Ther. 2024 Mar;12(1):131-145. doi: 10.1007/s40487-023-00255-2. Epub 2023 Dec 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CML (Chronic Myelogenous Leukemia), run by xuna at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact na xu, doctor (02062787883, 292347668@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05092048, which also lists 1 linked publication.
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 25 Oct 2021.