Hereditary Colorectal and Associated Tumor Registry Study | NCT00633607

Studies
Hereditary Colorectal and Associated Tumor Registry Study

NCT00633607

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Feb 19, 2018Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Lynch Syndrome
FAP
Hereditary Diffuse Gastric Cancer
Juvenile Polyposis Syndrome
Peutz-Jeghers Syndrome

Interventions

Research Registry

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

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jan 26, 2018Actual

Completion Date

Jan 26, 2018Actual

First Submitted Date

Mar 3, 2008

First Submission Date that Met QC Criteria

Mar 11, 2008

First Posted Date

Mar 12, 2008Estimated

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

Feb 15, 2018

Last Update Posted Date

Feb 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

Detailed Description

Not provided

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

114Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Research Registry	Other	Information regarding medical and family history is stored in the registry to be used for potential future studies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research.		1-N/A (up to 8 years)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Identified gene mutation
Personal history of colorectal cancer diagnosed ≤ 50
Personal history of cancer with tumor studies suggestive of Lynch syndrome
Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)
Personal history of one of the above cancers and a family history of one or more of the above cancers
Personal or family history of diffuse gastric cancer
From a known genetic predisposition family
Personal history of > 10 colon adenomas (cumulative over a lifetime)
Personal history of any number of hamartomatous polyps
Personal history of multiple large (> 1cm) serrated polyps to right of sigmoid

Exclusion critera:

Individuals under the age of 8
Individuals who cannot travel to Pittsburgh for in-person enrollment
Individuals who cannot provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Potential research subjects are recruited from our Hereditary GI clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randall E Brand, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15232	United States

Condition Browse Module

MeSH Terms

ID	Term
D003123	Colorectal Neoplasms, Hereditary Nonpolyposis
D013274	Stomach Neoplasms
C537702	Juvenile polyposis syndrome
D010580	Peutz-Jeghers Syndrome

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