Skip to main content
OpenTrials
Completed

NCT Number: NCT01098500

Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (age ≥18 years) with at least two ICD-9 codes for a particular cancer (ICD-9 code 140-208.9) within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code
  • At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and
  • Continuous enrolment in the LabRx database during follow-up.

Exclusion criteria

  • Less than 18 years old
  • Less than one month (30 days) of enrolment prior to index date or three months (91 days) of follow-up post index date; and
  • Not continuously enrolled in the LabRx database during follow-up.

Treatment and study plan

Tyrosine kinase inhibitors

Drug

Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)

Primary outcomes

  1. Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

  2. Incidence of ALT >=3x ULN

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Number of patients with ALT >=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT <1 times ULN at baseline.

  3. Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Prevalence of patients with Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

  4. Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Number of patients with Hy's Law (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL <1 times ULN at baseline.

Secondary outcomes

  1. Maximum ALT Elevation Reached During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up

  2. Median Time to the Maximum ALT Elevation During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Median time (in months) between index date and the date of maximum ALT elevation.

  3. Maximum AST Elevation Reached During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up

  4. Median Time to the Maximum AST Elevation During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Median time (in months) between index date and date of maximum AST elevation

  5. Maximum ALP Elevation Reached During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up

  6. Median Time to the Maximum ALP Elevation During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Median time (in months) between index date and date of maximum ALP elevation

  7. Maximum BIL Elevation Reached During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up

  8. Median Time to the Maximum BIL Elevation During Follow-up

    Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

    Median time (in months) between index date and date of maximum BIL elevation

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 2, 2010
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.