The Association Between Alpha 1 Acid Glycoprotein Level and Outcome Metastatic Cancer Treated With Docetaxel
1 other identifier
observational
200
1 country
1
Brief Summary
Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including 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 cancer patients. The investigators aim to prospectively study the association between the plasma level of alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMarch 25, 2013
March 1, 2013
3 years
March 5, 2013
March 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The association between the baseline plasma level of alpha 1 acid glycoprotein and progression free survival of docetaxel based therapy in patients with metastatic cancer
The association between the baseline plasma level of alpha 1 acid glycoprotein and progression free survival of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer
3 years
Secondary Outcomes (1)
The association between the baseline plasma level of alpha 1 acid glycoprotein and the response rate and overall survival of docetaxel based therapy in patients with metastatic cancer
3 years
Study Arms (1)
Oncology Institute, Meir Medical Center
Metastatic cancer patients treated with docetaxel at the Oncology Institute, Meir Medical Center
Eligibility Criteria
Patients with Metastatic cancer from lung, breast, gastric, prostate, and bladder origin, treated with docetaxel based chemotherapy
You may qualify if:
- patients with metastatic cancer from lung, breast, gastric, prostate, and bladder origin
- patients must be treated with docetaxel based chemotherapy
- patients must sign an informed consent form
You may not qualify if:
- patients with metastatic cancer other than lung, breast, gastric, prostate, and bladder origin
- patients treated with chemotherapy other than docetaxel
- patients that did not sign an informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gottfried Mayalead
Study Sites (1)
Institute of Oncology, Meir Medical Center
Kfar Saba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Keizman, MD
Meir Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head, Institution of Oncology
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 19, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2018
Last Updated
March 25, 2013
Record last verified: 2013-03