Molecular Genetic and Pathological Studies of Anal Tumors

Study the Genetics of Anal Cancer

Study Overview

• Status: Terminated
• Conditions: Rectal Cancer; Colon Cancer; Colonic Neoplasms; Anal Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with anal cancer or high risk for anal cancer refered to Stanford.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Mark Lane Welton, Stanford University

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 19, 2005
• First Submitted That Met QC Criteria: December 19, 2005
• First Posted (Estimate): December 21, 2005

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Colonic Neoplasms; Anus Neoplasms
• Other Study ID Numbers: ANAL0001 (Other Identifier: Stanford University); 95340 (Other Identifier: Stanford University Alternate IRB Approval Number); 14037 (Other Identifier: Stanford IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No