Suspended

The Association Between Alpha 1 Acid Glycoprotein Level and Outcome of Patients With Metastatic Cancer Treated With Docetaxel Based Chemotherapy

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Urogenital Diseases+28

+ Genital Diseases

+ Urinary Bladder Diseases

Over 18 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: April 2013

See protocol details

Summary

Principal SponsorGottfried Maya

Study ContactDaniel Keizman, MDMore contacts

Last updated: March 25, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer. One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in non small cell lung cancer patients. The investigators aim to prospectively study the association between the baseline plasma level of alpha 1 acid glycoprotein (measured on the first day of the first cycle of docetaxel) and the outcome (response rete, progression free survival, overall survival) of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, stomach cancer, prostate cancer, and bladder cancer.

NCT01814150

Principal SponsorGottfried Maya

Study ContactDaniel Keizman, MDMore contacts

Last updated: March 25, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUrinary Bladder DiseasesBreast DiseasesDigestive System DiseasesDigestive System NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleLung DiseasesNeoplasmsNeoplasms by SiteProstatic DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesStomach DiseasesThoracic NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsSkin and Connective Tissue DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Bladder NeoplasmsBreast NeoplasmsLung NeoplasmsProstatic NeoplasmsStomach Neoplasms

Criteria

3 inclusion criteria required to participate

patients must be treated with docetaxel based chemotherapy

patients must sign an informed consent form

patients with metastatic cancer from lung, breast, gastric, prostate, and bladder origin

3 exclusion criteria prevent from participating

patients that did not sign an informed consent form

patients treated with chemotherapy other than docetaxel

patients with metastatic cancer other than lung, breast, gastric, prostate, and bladder origin

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Institute of Oncology, Meir Medical Center

Kfar Saba, IsraelOpen Institute of Oncology, Meir Medical Center in Google Maps

SuspendedOne Study Center