ICARE: Inherited CAncer REgistry

Sponsor

Vanderbilt-Ingram Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03231891

Collaborator

(none)

10,000

Enrollment

Location

225.1

Anticipated Duration (Months)

44.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals interested in participating in studies focused on inherited cancer predisposition the opportunity to enroll in a research registry. Efforts through the registry include, but are not limited to, contribution of data to observational studies, targeted gene-specific studies, and education and outreach efforts for both participants and recruiting healthcare providers. Participants are given the opportunity to learn about and participate in other efforts for which they may be eligible.

All participants and recruiting healthcare providers receive educational newsletters twice per year which contain research and clinical updates in the field of cancer genetics. Providers who recruit patients can also access monthly web-based genetics case conferences which focus on different topics each month and are generally attended by a guest expert who provides background information on the topic as well as comments on the case presentations.

Participation in ICARE involves completion of an informed consent form, baseline questionnaire, follow-up questionnaires every two years, and medical record/tumor releases, as applicable. There is no cost to participate and all correspondence can be facilitated through phone, email, or mail.

Enrollment can be completed either through a traditional paper-based consenting method (i.e. postal mail) or through the online enrollment option available on the ICARE website (InheritedCancer.net). If you are a patient interested in learning more or a provider interested in recruiting to ICARE, please visit our website where you may complete an online contact form requesting a study team member contact you.

Condition or Disease	Intervention/Treatment	Phase
Cancer

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inherited CAncer REgistry (ICARE) Initiative

Actual Study Start Date :

Feb 27, 2017

Anticipated Primary Completion Date :

Dec 1, 2034

Anticipated Study Completion Date :

Dec 1, 2035

Outcome Measures

Primary Outcome Measures

Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations. [Up to 100 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

At least 18 years of age
Able and willing to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

Investigators

Principal Investigator: Tuya Pal, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Inherited Cancer Registry (ICARE) Website

Publications

None provided.

Responsible Party:

Tuya Pal, Associate Director for Cancer Health Disparities, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT03231891

Other Study ID Numbers:

VICC MD 1712

First Posted:

Jul 27, 2017

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 2, 2022