CancerICARENCT03231891
Inherited CAncer REgistry
An observational study of Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to Dec 2035
- How long will I take part?
- 100 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals interested in participating in inherited cancer research studies.
Who may be able to join
- At least 18 years of age
- Able and willing to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Anne Weidner, MPH, 615-875-2444, ICARE@vumc.org
Tuya Pal, MD
About this study
Official title: Inherited CAncer REgistry (ICARE) Initiative
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.
Read more
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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations.
Measured: Up to 100 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start27 Feb 2017
- Primary completionDec 2034 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuya Pal, Vanderbilt-Ingram Cancer Center
- Investigators
- Tuya Pal, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231891
- Sponsor's protocol ID
- VICC MD 1712
- Acronym
- ICARE
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2017
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inherited CAncer REgistry (ICARE) Initiative
- ClinicalTrials.gov ID
- NCT03231891
- Acronym / sponsor ID
- ICARE / VICC MD 1712
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals interested in participating in inherited cancer research studies.
Key inclusion criteria (2 listed)
- At least 18 years of age
- Able and willing to provide informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations.
Time frame: Up to 100 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Inherited Cancer Registry (ICARE) WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuya Pal, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Weidner, MPH (615-875-2444, ICARE@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations. (time frame: Up to 100 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.