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Molecular Genetic and Pathological Studies of Anal Tumors

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ClinicalTrials.gov Identifier: NCT00267787
Recruitment Status : Unknown
Verified July 2012 by Stanford University.
Recruitment status was:  Recruiting
First Posted : December 21, 2005
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
Study the Genetics of Anal Cancer

Condition or disease Intervention/treatment
Rectal Cancer Colon Cancer Colonic Neoplasms Anal Cancer Other: genetic analysis

Detailed Description:
To determine the status of previously identified anal cancer molecular markers and any correlations with outcome as well as to discover new molecular biomarkers through correlating molecular data with clinical outcome. Study of tissue samples and cells from biopsies of your lesion and blood sample. We hope to learn the role genes and proteins may play in the development of anal cancer. Experiments will be performed using this tissue and blood, include analysis of DNA, analysis of RNA expression levels, analysis of protein levels of important gene products, and development of tissue culture cell lines.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Genetic and Pathological Studies of Anal Tumors
Study Start Date : September 2004
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
U.S. FDA Resources

Groups and Cohorts
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Intervention Details:
    Other: genetic analysis
    standard of care

Outcome Measures
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Primary Outcome Measures :
  1. Genetic analysis of blood sample as well as tissues , will provide us with any possible tumor marker for a better prognostic indicator. [ Time Frame: Annual assessment. ]

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with anal cancer or high risk for anal cancer refered to Stanford.
Criteria

Inclusion Criteria:Inclusion Criteria:

  • Patients with anal tumors
  • Undergoing surgery for elective colon and rectal surgery

Exclusion Criteria:No other patients other than adult patients with anal cancer or high risk for anal cancer refered to Stanford will be enrolled to the study. No Children will be included to the study

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267787


Contacts
Contact: Moe Jalali (650) 724-4023 moej@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Moe Jalali    650-724-4023    moej@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Mark Lane Welton         
Sub-Investigator: Nader Pourmand         
Sub-Investigator: Dr Andrew Shelton         
Sub-Investigator: George Albert Fisher M.D. Ph.D.         
Sub-Investigator: James M Ford         
Sub-Investigator: Hanlee P. Ji         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Mark Lane Welton Stanford University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00267787     History of Changes
Other Study ID Numbers: ANAL0001
95340 ( Other Identifier: Stanford University Alternate IRB Approval Number )
ANAL0001 ( Other Identifier: Stanford University )
First Posted: December 21, 2005    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Anus Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Colonic Diseases