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Genetic Counseling for Cancer Syndromes (CHARM Trial)
N/A
Waitlist Available
Led By Michael Leo, 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one month of specimen receipt at the laboratory
Awards & highlights
CHARM Trial Summary
This trial will help assess the utility of clinical exome sequencing and how it affects care in diverse populations.
Who is the study for?
Adults aged 18-49 who are at risk for hereditary cancer syndromes can join this trial. They must be patients of Kaiser Permanente Northwest or Denver Health, have not been tested for familial mutations like Lynch syndrome or breast and ovarian cancer, and speak English or Spanish.Check my eligibility
What is being tested?
The CHARM study is testing how useful clinical exome sequencing is in primary care settings to assess hereditary cancer risks. It compares traditional genetic counseling with a modified version tailored for those with low health literacy.See study design
What are the potential side effects?
Since the interventions involve genetic counseling and assessments rather than medications, typical drug side effects are not expected. However, participants may experience emotional or psychological impacts from learning about their genetic risks.
CHARM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post result disclosure, 6 months post result disclosure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post result disclosure, 6 months post result disclosure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive findings for hereditary cancer syndromes
Secondary outcome measures
Comparison of Healthcare Utilization measured via Electronic Medical Record (EMR) data
Family communication
Participant satisfaction of genetic counseling
+5 moreCHARM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Modified genetic counselingExperimental Treatment1 Intervention
This will be genetic counseling that is modified for a lower literacy patient and will include fewer technical terms and less complicated genetic information.
Group II: Traditional genetic counselingActive Control1 Intervention
This will be typical genetic counseling that a patient would receive in a traditional genetic counseling setting.
Find a Location
Who is running the clinical trial?
University of WashingtonOTHER
1,739 Previous Clinical Trials
1,846,961 Total Patients Enrolled
Denver Health and Hospital AuthorityOTHER
101 Previous Clinical Trials
399,430 Total Patients Enrolled
Emory UniversityOTHER
1,638 Previous Clinical Trials
2,559,565 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not been tested for specific gene mutations related to Lynch syndrome or hereditary breast and ovarian cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Modified genetic counseling
- Group 2: Traditional genetic counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available for this trial?
"The clinicaltrials.gov portal reveals that recruitment for this trial has been closed since June 7, 2022. Initially posted on August 15th 2018, the study is no longer seeking patients; however there are 6 other trials actively recruiting at present."
Answered by AI
Does the study allow for elderly participants?
"This clinical trial is restricted to individuals between the ages of 18 and 49, as indicated by its inclusion criteria."
Answered by AI
Who meets the criteria for participating in this research project?
"This research requires the recruitment of 967 participants between 18 and 49 with a familial history or risk assessment that points to hereditary cancer. Additionally, they must not have had previous testing for Lynch Syndrome or breast/ovarian cancers, and be registered at Kaiser Permanente Northwest or Denver Health."
Answered by AI
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