NCT03231891

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
113mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Feb 2017Dec 2035

Study Start

First participant enrolled

February 27, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
17.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2034

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

17.8 years

First QC Date

July 24, 2017

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals interested in participating in inherited cancer research studies.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37212, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood, saliva/cheek swab, urine, and/or other biological specimens may be requested from participants. Tissues saved during previous surgeries as part of the patient's treatment may be requested.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Tuya Pal, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Weidner, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
100 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director for Cancer Health Disparities

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 27, 2017

Study Start

February 27, 2017

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2035

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations