Molecular Genetic and Pathological Studies of Anal Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00267787
First received: December 19, 2005
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

Study the Genetics of Anal Cancer


Condition Intervention
Rectal Cancer
Colon Cancer
Colonic Neoplasms
Anal Cancer
Other: genetic analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Genetic and Pathological Studies of Anal Tumors

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 300
Study Start Date: September 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: genetic analysis
    standard of care
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00267787     History of Changes
Other Study ID Numbers: ANAL0001, 95340, ANAL0001
Study First Received: December 19, 2005
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014