- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00267787
Molecular Genetic and Pathological Studies of Anal Tumors
December 6, 2018 updated by: Stanford University
Study the Genetics of Anal Cancer
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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.
Time Frame: Annual assessment.
|
Annual assessment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Lane Welton, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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