Molecular Genetic and Pathological Studies of Anal Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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:

MedlinePlus related topics: Anal Cancer

Genetic and Rare Diseases Information Center resources: Anal Cancer

U.S. FDA Resources

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. ]

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:

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 (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

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


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 )
Study First Received:	December 19, 2005
Last Updated:	July 5, 2012

Additional relevant MeSH terms:


Rectal Neoplasms Anus Neoplasms Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site	Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Anus Diseases Colonic Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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