Prevalence and Spectrum of Cancer Susceptibility Among Pa... | NCT04160832

Studies
Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps

NCT04160832

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Jan 15, 2025Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Colorectal Neoplasm

Interventions

Multi-Cancer Cancer Panel

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

Jan 2025

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

Oct 24, 2019Actual

Primary Completion Date

Aug 30, 2024Actual

Completion Date

Aug 30, 2024Actual

First Submitted Date

Nov 8, 2019

First Submission Date that Met QC Criteria

Nov 8, 2019

First Posted Date

Nov 13, 2019Actual

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

Jan 13, 2025

Last Update Posted Date

Jan 15, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-Cancer Cancer Panel	Genetic	Eligible patients will receive genetic testing to determine germline cancer predisposition.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps		3 years

Secondary Outcomes

Measure	Description	Time Frame
Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision to sign and date the consent form
Stated willingness to comply with all study procedures and be available for the duration of the study
Be a male or female aged 18-89
Undergone colonoscopy
At least one advanced colorectal polyp, defined as having any of the following:
Any polyp ≥ 1cm (adenoma or serrated polyp)
Any polyp with villous architecture
Any polyp with high-grade dysplasia
Sessile serrated polyps with any dysplasia
Traditional serrated adenoma

Exclusion Criteria:

Known hereditary cancer syndrome
Personal history of inflammatory bowel disease
Personal history of colorectal cancer
Polyp histology or size unavailable or not documented

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Males and females aged 18 - 89, who have been diagnosed with advanced colorectal polyps.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Swati Patel, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Denver		Aurora	Colorado	80045	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
D015179	Colorectal Neoplasms
D011127	Polyps
D009369	Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided