NCT00369109

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

August 24, 2006

Last Update Submit

April 5, 2013

Conditions

Breast CancerColorectal CancerPancreatic Cancer

Keywords

recurrent colon cancerstage III colon cancerstage IV colon cancerrecurrent rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

Interventions

biologic sample preservation procedureOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of advanced solid tumor malignancy (preferably colorectal, pancreatic, or breast cancer) * Scheduled to receive a standard dose, weekly regimen of either irinotecan hydrochloride or gemcitabine hydrochloride PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * No DNA-damaging agent within the past 13 days

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

ImmunohistochemistryBiopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Patricia M. LoRusso, DO

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 29, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2006

Study Completion

June 1, 2007

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

US(1)GB(1)