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Cancer Risk Assessment for Hereditary Cancer Risk

Waitlist Available
Led By Douglas Corley, MD, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 0 to 12 months
Awards & highlights

Study Summary

This trial will compare three methods for identifying and risk-stratifying individuals at risk of hereditary cancer, and providing post-risk stratification longitudinal care.

Who is the study for?
This trial is for adults who've been members of Kaiser Permanente Northern California for at least 2 years, have visited a clinic in the past two years, and have an email on file. It's not open to those outside the targeted area, in the no-contact database, or unable to read English.Check my eligibility
What is being tested?
The study compares three methods of identifying and managing individuals at risk of hereditary cancers like colorectal and breast cancer. Participants will either receive usual care or go through an online cancer risk assessment tool.See study design
What are the potential side effects?
Since this trial involves non-medical interventions such as usual care and online assessments rather than drugs or medical procedures, traditional side effects are not applicable.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients identified at high risk of cancer

Trial Design

3Treatment groups
Experimental Treatment
Group I: Comparator 3Experimental Treatment1 Intervention
Participants will have their cancer risk assessed using a more detailed, full version of the family history survey than the one comparator 2 participants take. This version is a full pedigree assessment, which entails family health history for all 1st, 2nd, and 3rd-degree relatives. Time needed for completion is 15-25 minutes, depending on family size and cancer risk. Participants will also be asked to take the PRO survey following the full cancer risk assessment and also at 6 and 12 months.
Group II: Comparator 2Experimental Treatment1 Intervention
Participants will have their cancer risk assessed using a short, standardized web-based questionnaire that will populate validated cancer risk models (such as Breast Cancer Risk Assessment Tool/Gail model 2, PREMM and/or MMRpro) which will take 5-10 minutes to complete. Following the cancer risk assessment, participants will be asked to take a PRO survey. PRO surveys will also be administered at the time of the cancer risk assessment and then 6 and 12 months following.
Group III: Comparator 1Experimental Treatment1 Intervention
Participants will have their cancer risk assessed via usual care. Usual Care is defined as provider capture of family history during a clinical encounter and its entry into the electronic health record (EHR). Participants will take the a patient reported outcomes (PRO) survey once to assess participants experience, perspectives and thoughts on cancer, cancer risk, and cancer risk assessments.

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
540 Previous Clinical Trials
23,887,677 Total Patients Enrolled
7 Trials studying Breast Cancer
3,729,050 Patients Enrolled for Breast Cancer
Patient-Centered Outcomes Research InstituteOTHER
554 Previous Clinical Trials
29,929,728 Total Patients Enrolled
7 Trials studying Breast Cancer
1,480,170 Patients Enrolled for Breast Cancer
Douglas Corley, MD, PhDPrincipal InvestigatorDivision of Research, Kaiser Permanente Northern California

Media Library

Usual care Clinical Trial Eligibility Overview. Trial Name: NCT04145388 — N/A
Breast Cancer Research Study Groups: Comparator 1, Comparator 2, Comparator 3
Breast Cancer Clinical Trial 2023: Usual care Highlights & Side Effects. Trial Name: NCT04145388 — N/A
Usual care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145388 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this clinical experiment?

"Affirmative. As indicated on clinicaltrials.gov, the recruitment process for this trial has been ongoing since July 1st 2020 and most recently updated in October 19th 2021. 18000 participants need to be enrolled at one centre."

Answered by AI

Is enrollment for this research project still accessible to participants?

"According to the clinicaltrials.gov portal, this trial is actively searching for participants. The original posting date was July 1st 2020 and it has been edited most recently on October 19th 2021."

Answered by AI

Are individuals over the age of 50 eligible for enrollment in this clinical trial?

"Participants aged between 25 and 75 years old are sought for this clinical trial."

Answered by AI

Am I an eligible candidate for this research program?

"To meet the prerequisites of admission, those interested must possess Lynch Syndrome and be between the ages of 25 to 75. The trial is aiming to recruit 18000 participants in total."

Answered by AI
~3853 spots leftby May 2025