Chart Review: Unresectable/Metastatic Cholangiocarcinoma... | NCT00320918

Studies
Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib

NCT00320918

Sponsor

University of New Mexico

Status

Terminated

Last Update Posted

Jan 12, 2024Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Cholangiocarcinoma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This was a Chart Review only and was entered in the system in error.

Expanded Access Info

Start Date

Nov 2005Actual

Primary Completion Date

Aug 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Apr 28, 2006

First Submission Date that Met QC Criteria

Apr 28, 2006

First Posted Date

May 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2024

Last Update Posted Date

Jan 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chart Review on Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Detailed Description

As above.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Exclusion Criteria:

Not specified.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fa-Chyi Lee, MD	University of New Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of New Mexico		Albuquerque	New Mexico	87131	United States

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma
D009369	Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided