Lung CancerNCT03802409
The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment
An observational study of Lung Cancer, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2019to 30 Jun 2020
- 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: Confirmed by Histopathology or Cytology of Lung cancer
Who may be able to join
- Male or female patients .
- Confirmed by Histopathology or Cytology of Lung Cancer
- Patients should be voluntary to the trial and provide with signed informed consent
- The researchers believe patients can benefit from the study.
Who cannot join
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to Albumin-binding taxol or its accessories
- Pregnant or lactating women
- Patients with Albumin-binding taxol contraindications
- Patients of doctors considered unsuitable for the trial
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .
- Conditions
- Lung Cancer
- Keywords
- Albumin-binding taxol
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Measured: 1 year
Secondary outcomes (3)
Overall Survival
overall survival is defined as the length of time from random assignment to death or to last contact.
Measured: 3 year
disease control rate
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1
Measured: 1 year
Objective tumor response rate
Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments
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 posted14 Jan 2019
- Study start20 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802409
- Sponsor's protocol ID
- AHAT-105
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment
- ClinicalTrials.gov ID
- NCT03802409
- Acronym / sponsor ID
- AHAT-105
- Conditions
- Lung Cancer
- Keywords
- Albumin-binding taxol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 14 Jan 2019 (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.
The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed by Histopathology or Cytology of Lung cancer
Key inclusion criteria (4 listed)
- Male or female patients .
- Confirmed by Histopathology or Cytology of Lung Cancer
- Patients should be voluntary to the trial and provide with signed informed consent
- The researchers believe patients can benefit from the study.
Key exclusion criteria (4 listed)
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to Albumin-binding taxol or its accessories
- Pregnant or lactating women
- Patients with Albumin-binding taxol contraindications
- Patients of doctors considered unsuitable for the trial
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
Progress free survival
Time frame: 1 year
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
3 secondary outcomes
Overall Survival
Time frame: 3 year
disease control rate
Time frame: 1 year
Objective tumor response rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer, run by The First Affiliated Hospital of Anhui Medical University 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 4 inclusion and 4 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 22 Jan 2019. 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?
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?
Progress free survival (time frame: 1 year). 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 22 Jan 2019.