Identifying and Caring for Individuals With Inherited Cancer Syndrome (NCT04494945) | Clinical Trial Compass
RecruitingNot Applicable
Identifying and Caring for Individuals With Inherited Cancer Syndrome
United States27,500 participantsStarted 2020-03-09
Plain-language summary
This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ALL COHORTS: 18 years of age or older
* Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent
* Retrospective COHORT A: Patients may or may not be diagnosed with cancer
* Retrospective COHORT A: Patients have received genetic counseling in the past 5 years
* Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
* COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent
* COHORT A: Patients may or may not be diagnosed with cancer
* COHORT A: Patients have received genetic counseling in the past 1 - 2 years
* COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
* COHORT A: INCLUSIVE of no contact list to exclude from Cohort B
* COHORT B: Creation of secure Healthy Oregon Project (HOP) app account
* COHORT B: Consent to this project, either hard or electronic signature
* COHORT B: Consent to the HOP repository, either hard or electronic signature
* COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample
* COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer
* COHORT B: Must have had an encounter within past twelve months
* COHORT B: Exclude Cohort A
* COHORT C: Creation of secure Hop app account
* COHORT C: Consent to this project, either hard or electronic sign…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
Timeframe: Up to 5 years
2
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
Timeframe: Up to 5 years
3
Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging
Timeframe: Up to 5 years
4
Cascade screening rate among Lynch or HBOC positive carriers