Molecular Genetic and Pathological Studies of Anal Tumors | NCT00267787

Studies
Molecular Genetic and Pathological Studies of Anal Tumors

NCT00267787

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Dec 10, 2018Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Rectal Cancer
Colon Cancer
Colonic Neoplasms
Anal Cancer

Interventions

genetic analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
95340	Other Identifier	Stanford University Alternate IRB Approval Number
ANAL0001	Other Identifier	Stanford University
14037	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2017Actual

First Submitted Date

Dec 19, 2005

First Submission Date that Met QC Criteria

Dec 19, 2005

First Posted Date

Dec 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2018

Last Update Posted Date

Dec 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study the Genetics of Anal Cancer

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

7Actual

Name	Type	Description	Arm Group Labels	Other Names
genetic analysis	Other	standard of care

Outcomes Module

Primary Outcomes

Measure	Description	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Lane Welton	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D003110	Colonic Neoplasms
D001005	Anus Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided