Collection of Skin Biopsy With Hair Follicles as Surrogate to Develop Biomarker Assays From Patients With Advanced Solid Tumor Malignancies Receiving Either Single Agent Weekly Irinotecan or Gemcitabine
Sponsor study identifier
Secondary identifiers
observational
60
2 countries
2
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Study Completion
June 2007
Actual (reported)RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This laboratory study is collecting skin biopsy specimens from patients receiving irinotecan or gemcitabine for advanced solid tumors and using them to study change in DNA due to this treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
August 24, 2006
Actual (reported)August 29, 2006
Actual (reported)November 2006
Actual (reported)June 2007
Actual (reported)Level of p-Chk1 and phospho-histone 2AX (p-H2AX) and possibly downstream pathway markers in hair follicles from skin biopsies of patients treated with gemcitabine hydrochloride or irinotecan hydrochloride for advanced solid tumors
Characterization of the method for measurement (immunohistochemistry)
Inter- and intra-patient variability for the biomarker
Dynamic time course of p-Chk1 and p-H2AX after administration of a DNA-damaging agent
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Christie Hospital NHS Trust
Manchester, England, M20 4BX, United Kingdom
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute
First Submitted
August 24, 2006
First Posted
August 29, 2006
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Study Completion
June 2007
Actual (reported)Last Updated
April 8, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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