Study of a Blood Test to Look for Signs of Cancer in Higher-Risk People (CHARM2)

https://www.facingourrisk.org/research-clinical-trials/study/393 /study-of-a-blood-test-to-look-for-signs-of-cancer-in-higher-risk-people-charm2

Clinicaltrials.gov identifier:
NCT06726642 (https://clinicaltrials.gov/show/NCT06726642)

Prevention
Observational study of a blood test for finding possible cancers earlier in people who have a high risk of cancer

Study Contact Information:

Study Contact

Name: Julia Sobotka, MSc
Phone Number: 416-409-1387
Email: [email protected]

About the Study

This study is looking at how well an experimental blood test works for finding possible cancers earlier in people who have a higher-than-average risk of cancer because of an inherited mutation, including BRCA1, BRCA2, CDH1, EPCAM, MLH1, MSH2, MSH6, NF1, PALB2, PMS2, and TP53. Researchers will compare people who get the blood test plus their usual cancer screening with people who continue with usual screening alone. The study will also look at whether the blood test is linked with cancers being found at an earlier stage and how receiving blood test results affects quality of life and stress.

What the Study Involves

If you join, you will be randomly assigned to one of two groups. You and the study team will know which group you are in.

Group 1: (Blood Test)

Provide blood samples about every 4 months for up to 4 years (either at the study hospital or a local lab)
Keep getting your regular, recommended cancer screening
Fill out short questionnaires and, for some people, take part in interviews about your experience with the blood test

Group 2: (Standard Cancer Screening)

Keep getting your regular, recommended cancer screening
Fill out short questionnaires and, for some people, take part in interviews about your experience with cancer screening and monitoring

This Study is Open To:

You may be able to join this study if you:

Have an inherited mutation, including BRCA1, BRCA2, CDH1, EPCAM, MLH1, MSH2, MSH6, NF1, PALB2, PMS2, and TP53
- This may include people with a confirmed genetic mutation, or people whose genetic testing did not find a clear answer but whose family history strongly suggests one of these syndromes
Are already getting standard (usual) cancer screening or surveillance with a managing healthcare provider

This Study is Not Open To:

You may not join the study if you:

Have had cancer that was diagnosed and treated within the last 3 years (if you have had cancer before, your treatment must have been completed successfully at least 3 years before your first study blood draw)
Were diagnosed with cancer more than 3 years ago but did not receive treatment for that cancer
Are currently having tests to check for a suspected cancer
Would not be able to follow the study requirements (for example, coming in for regular blood draws if assigned to the blood test group)

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.