NCT03802409

Brief Summary

The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 10, 2019

Last Update Submit

January 18, 2019

Conditions

Lung Cancer

Keywords

Albumin-binding taxol

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (3)

  • Overall Survival

    3 year

  • disease control rate

    1 year

  • Objective tumor response rate

    1 year

Other Outcomes (2)

  • Quality of life score

    1 year

  • adverse events

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Confirmed by Histopathology or Cytology of Lung cancer

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

January 20, 2019

Primary Completion

January 1, 2020

Study Completion

June 30, 2020

Last Updated

January 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within six months after the trial complete.
Access Criteria
The data will be disclosed within six months after completion of the study.

Locations

CN(1)