NCT03699579

Brief Summary

This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

October 5, 2018

Last Update Submit

August 23, 2019

Conditions

Keywords

advanced or metastatic renal cell carcinoma (RCC)

Outcome Measures

Primary Outcomes (2)

  • Medication usage

    From start point for 2.5 months

  • Treatment's duration

    From start point for 2.5 months

Secondary Outcomes (4)

  • Cost of medication used

    From start point for 2.5 months

  • Costs of adverse event management

    From start point for 2.5 months

  • Frequency of health resource usage

    From start point for 2.5 months

  • Cost of health resource usage

    From start point for 2.5 months

Eligibility Criteria

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

Hospital chart review study

You may qualify if:

  • Patients with confirmed diagnosis of clear-cell renal cell carcinoma
  • Patients with evidence of metastatic disease
  • Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib
  • Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

You may not qualify if:

  • Patients enrolled in any clinical trial involving anti-cancer therapy
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

February 22, 2019

Primary Completion

June 23, 2019

Study Completion

June 23, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations