AnemiaNCT01030159
National Cancer Institute Thai Cancer Anemia Survey
An observational study of Anemia and Cancer, run by Janssen-Cilag Ltd.,Thailand at 1 site in Thailand.
Trial summary
The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Adult Cancer Patients
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2006to May 2008
- 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: Anemic patients with cancer receiving chemotherapy
Who may be able to join
- Patients with cancer
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anemia Survey in Cancer Patients Study
The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.
Read the detailed description
Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered
- Being tested
- Adult Cancer Patients
- Keywords
- Cancer Anemia Survey, Thai National Cancer Institute
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult Cancer PatientsOther
Tracking anemia management in Adult Cancer Patients
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Adult Cancer Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that have anemia during cancer therapy
Measured: 6 months
Secondary outcomes (1)
Characteristics of patients example treatment duration, type of chemotherapy used, grade of anemia
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 posted11 Dec 2009 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.,Thailand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030159
- Sponsor's protocol ID
- CR012703
- Other IDs
- TCAS-NCI-ONCO-2006
- Status last verified
- Apr 2014
- First submitted
- 10 Dec 2009
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia Survey in Cancer Patients Study
- ClinicalTrials.gov ID
- NCT01030159
- Acronym / sponsor ID
- CR012703
- Keywords
- Cancer Anemia Survey, Thai National Cancer Institute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Dec 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 create a large Thailand database documenting the severity of anemia and its management in the cancer population.
Detailed description
Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Adult Cancer Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anemic patients with cancer receiving chemotherapy
Key inclusion criteria (1 listed)
- Patients with cancer
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Adult Cancer PatientsTracking anemia management in Adult Cancer Patients | Other | 001 |
Primary outcome
Number of patients that have anemia during cancer therapy
Time frame: 6 months
1 secondary outcome
Characteristics of patients example treatment duration, type of chemotherapy used, grade of anemia
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 9 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 Ltd Clinical Trial study director
Janssen-Cilag Ltd.
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 Anemia and Cancer, run by Janssen-Cilag Ltd.,Thailand at 1 site in Thailand.
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 1 inclusion and 1 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 9 Apr 2014. 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 Thailand. 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?
Number of patients that have anemia during cancer therapy (time frame: 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 9 Apr 2014.