NCT01294085

Brief Summary

To assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 28, 2011

Status Verified

November 1, 2011

Enrollment Period

3 months

First QC Date

January 3, 2011

Last Update Submit

November 24, 2011

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • One year survival rate

    1 year

Secondary Outcomes (3)

  • Overall survival time

    3 years

  • Number of participants with adverse events

    3 years

  • Progression free survival

    3 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

300

You may qualify if:

  • Unresectable or recurrent biliary tract cancer

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Tatsuya Ioka, MD

    Osaka Medical Center for Cancer and CVD

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

February 11, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

August 1, 2011

Last Updated

November 28, 2011

Record last verified: 2011-11

Locations

JP(1)