Care Tracking for Genetic Cancer Syndromes

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Overseen ByJose Rauh-Hain, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women with high-risk genetic mutations linked to breast and ovarian cancer manage their health better and reduce their cancer risk. Initially, the study involves interviews to develop a user-friendly digital app called ACT-GEN, followed by testing the app's effectiveness. It seeks women who are aware of specific genetic mutations in genes like BRCA1/2 or Lynch syndrome genes, speak English or Spanish, and have a compatible smartphone. As an unphased trial, participants can contribute to innovative research that may improve health management tools for those at risk.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are actively being treated for cancer with cytotoxic therapy, you may not be eligible to participate.

What prior data suggests that this protocol is safe for participants?

Research shows that ACT-GEN, the treatment used in this study, focuses on genetic testing for hereditary cancer syndromes. Most people find genetic testing easy to handle. It involves examining DNA from a blood sample to detect genetic changes that might increase cancer risk. No major side effects have been reported from the testing process itself.

The safety of ACT-GEN centers on accurately identifying people at risk without causing harm. Studies have shown that these tests are accurate and safe, with a 90-95% accuracy rate for detecting harmful genetic changes. This indicates that the process is reliable and poses minimal risk to participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Care Tracking for Genetic Cancer Syndromes trial because it aims to revolutionize patient care with a personalized digital approach. Unlike traditional treatments that focus solely on physical interventions like surgery, chemotherapy, or radiation, this study is developing and testing a patient-centered digital application designed to enhance ongoing care and monitoring. By integrating patient feedback into its design, the application promises to tailor support and tracking for individuals with genetic cancer syndromes, potentially leading to better outcomes and more personalized care management.

What evidence suggests that this trial's treatments could be effective for genetic cancer syndromes?

Research has shown that screening for cancers such as breast, colon, or cervical cancer can lead to better outcomes and lower risks. Studies have found that genetic testing for inherited cancer conditions is crucial for identifying individuals at higher risk. This identification aids in planning regular check-ups and preventive measures. In this trial, the ACT-GEN treatment is designed to help patients adhere to these guidelines. Although detailed data on ACT-GEN's effects remain limited, genetic testing in general has proven to significantly enhance the monitoring and early detection of cancer risks.16789

Who Is on the Research Team?

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Jose Rauh-Hain, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women age 18 or older who have a known harmful mutation in BRCA1, BRCA2, or certain Lynch syndrome genes (MLH1, MSH2, MSH6, PMS2, EPCAM). Participants must speak English or Spanish and have a compatible smartphone.

Inclusion Criteria

I am 40 or older and have a harmful BRCA2 gene mutation.
I am 18 years old or older.
I meet the study's requirements to participate.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Design and Development

Qualitative study including interviews to help design a patient-centered digital application

6 months

Feasibility Study

Participants are randomized to study arms to assess feasibility of the intervention

1 year

Follow-up

Participants are monitored for safety and adverse events

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ACT-GEN

Trial Overview

The study looks at whether regular interviews and tracking can help people with high-risk genetic cancer mutations follow recommended screening and care. All participants receive standard medical advice; some also get extra support through interviews.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: Feasibility study with two-arm randomizationExperimental Treatment1 Intervention
Group II: Part 1: Design and developmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Hereditary Cancer Genetic Testing: 30 Years of Impact ... - PMC

It is well understood that population-based screening for cancers such as breast, colon, or cervical cancer provide improve outcomes and reduce ...

ACT-GEN (Adherence And Care Tracking In GENetic ...

These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, ...

a randomized controlled trial to test cell-free DNA-based ...

Distress, anxiety, and depression in persons with hereditary cancer syndromes: Results from a nationwide cross-sectional study in Germany.

Genetic Testing for Cancer: New Evidence Questions ...

Genetic tests work well for people with a known risk, but their reliability drops when applied to the general public. Even a test with 99% ...

Hereditary Cancer Syndromes and Risk Assessment

A hereditary cancer risk assessment is the key to identifying patients and families who may be at increased risk of developing certain types of cancer.

ACTRisk

ACTRisk™ hereditary gene testing decodes 67 cancer genes associated with 9 common hereditary cancers and 11 cancer syndromes, which provides additional ...

Hereditary Cancer Syndromes: A Comprehensive Review with ...

We searched the available literature to comprehensively review and categorize hereditary cancer syndromes affecting adults with the aim of helping clinicians.

ACTRisk

Provides Information on 67 Hereditary Cancer Genes. The test can be done with just one blood draw, and a comprehensive evaluation of 9 major hereditary cancers ...

Genetic Testing Fact Sheet - NCI

A fact sheet about genetic testing for inherited cancer risk. Includes who should consider testing, and how to understand test results.