Stage IV Cancer (Solid Tumors Only)NCT01843985
Observational Study of Survival Outcomes of Stage IV Cancer Patients
An observational study of Stage IV Cancer (Solid Tumors Only) and Survival, run by Cure Cancer Worldwide Corporation at 1 site in China.
Trial summary
Patients diagnosed with Stage IV cancer (solid tumors only) are evaluated to determine whether they are candidates for traditional chemotherapy. If eligible, patients are offered traditional chemotherapy, low-dose chemotherapy, or palliative care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage IV Cancer (Solid Tumors Only), Survival
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Presenting with Stage IV cancer (solid tumors only)
Who cannot join
- Patient declines inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Survival Times of Stage IV Cancer Patients
Patients diagnosed with Stage IV cancer (solid tumors only) are evaluated to determine whether they are candidates for traditional chemotherapy. If eligible, patients are offered traditional chemotherapy, low-dose chemotherapy, or palliative care. If ineligible, patients are offered low-dose chemotherapy or palliative care. Patients will be monitored for 5 years and survival data recorded.
- Conditions
- Stage IV Cancer (Solid Tumors Only), Survival
- Keywords
- Stage IV cancer, Survival
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Eligible RCT/Elect RCT | Eligible for regular chemotherapy, elects and receives regular chemotherapy | |
| 2. Eligible RCT/Elect LDC | Eligible for regular chemotherapy, elects and receives low-dose chemotherapy | |
| 3. Eligible RCT/Elect PCO | Eligible for regular chemotherapy, elects and receives palliative care only | |
| 4. Ineligible RCT/Elect LDC | Ineligible for regular chemotherapy, elects and receives low-dose chemotherapy | |
| 5. Ineligible RCT/Elect PCO | Ineligible for regular chemotherapy, elects and receives palliative care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Cancer (Solid Tumors Only)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
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cure Cancer Worldwide Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843985
- Sponsor's protocol ID
- YLDZH-OS-1
- Status last verified
- Apr 2013
- First submitted
- 27 Apr 2013
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Survival Times of Stage IV Cancer Patients
- ClinicalTrials.gov ID
- NCT01843985
- Acronym / sponsor ID
- YLDZH-OS-1
- Conditions
- Stage IV Cancer (Solid Tumors Only), Survival
- Keywords
- Stage IV cancer, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cure Cancer Worldwide CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 May 2013 (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.
Patients diagnosed with Stage IV cancer (solid tumors only) are evaluated to determine whether they are candidates for traditional chemotherapy. If eligible, patients are offered traditional chemotherapy, low-dose chemotherapy, or palliative care. If ineligible, patients are offered low-dose chemotherapy or palliative care. Patients will be monitored for 5 years and survival data recorded.
Study design
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. Eligible RCT/Elect RCT | – | –Eligible for regular chemotherapy, elects and receives regular chemotherapy |
| 2. Eligible RCT/Elect LDC | – | –Eligible for regular chemotherapy, elects and receives low-dose chemotherapy |
| 3. Eligible RCT/Elect PCO | – | –Eligible for regular chemotherapy, elects and receives palliative care only |
| 4. Ineligible RCT/Elect LDC | – | –Ineligible for regular chemotherapy, elects and receives low-dose chemotherapy |
| 5. Ineligible RCT/Elect PCO | – | –Ineligible for regular chemotherapy, elects and receives palliative care only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Presenting with Stage IV cancer (solid tumors only)
Key exclusion criteria (1 listed)
- Patient declines inclusion
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
survival
Time frame: months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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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 Stage IV Cancer (Solid Tumors Only) and Survival, run by Cure Cancer Worldwide Corporation 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?
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: status not confirmed, as of the sponsor's last update on 1 May 2013. 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 gary smith (5207492035, garylsmith2@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60). 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 1 May 2013.