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Have you been diagnosed with Lynch Syndrome ?

Lynch Syndrome (LS) increases the risk of colon cancer and can also increase the risk of other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin and brain. Cancer prevention strategies for people with LS are therefore urgently needed. Using vaccines to train the body’s own immune system to prevent polyps and cancers is a new approach that we plan to test in patients with LS.

 

We are asking you to take part in this research study because you have been diagnosed with Lynch syndrome and your doctor has previously found polyps or cancer in your colon or rectum. This study is being done to find out if we can lower your chance of getting colon cancer and other Lynch cancers by giving you three vaccines, an approach called Tri-Ad5, in combination with an injectable immune-enhancer protein called N-803.

 

The usual approach for patients with Lynch syndrome is to be followed closely by their doctor with regular colonoscopies, pelvic imaging (ultrasounds), urine tests, computerized tomography scans (CT scans), and skin examinations to watch for the development of cancer. Removal of the colon or uterus before cancer develops is also part of the usual approach. We are doing this study because we want to find out if the vaccines we are testing will be effective at preventing colon polyps and cancers of the colon and other organs.

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NWU2015-06-03

Testing a combination of vaccines for cancer prevention in Lynch Syndrome

The purpose of this study is to compare the safety and effects of the Tri-Ad5 vaccines alone, or in combination with N-803, versus placebo on the risk of developing colon and other cancers in patients with Lynch syndrome. The Tri-Ad5 vaccines and N-803 are not FDA-approved.

 

This study is looking for volunteers who have been diagnosed with Lynch syndrome. We will enroll 158 participants at institutions across the country.

 

You may be eligible if:

  • You have been diagnosed with Lynch syndrome and have had abnormal growths in your colon or rectum.

  • You have not had any cancer treatment in the past 6 months.

  • You are 18 years or older.

  • You are not pregnant or planning to get pregnant.

 

If you think you may be eligible, you can contact ncpc@northwestern.edu to refer you to the study team closest to you.

Site: University of Kansas Medical Center, Kansas City, KS

Protocol and Site Principal Investigator: Ajay Bansal, MD

Site: University of Texas MD Anderson Cancer Center, Houston, TX

Protocol and Site Principal Investigator: Eduardo Vilar-Sanchez, MD, PhD

Site: Northwestern University, Chicago, IL

Investigator: Mohammad Abbass, MD

Site: Cleveland Clinic, Cleveland, OH

Investigator: Carol Burke, MD

Site: University of Puerto Rico, San Juan, Puerto Rico

Investigator: Marcia R. Cruz-Correa, M.D., Ph.D., AGAF, FASGE

Site: Ohio State University, Columbus, OH

Investigator: Peter Stanich, MD

Site: University of Utah, Salt Lake City, UT

Investigator: Joanne Jeter, MD, MS

Site: Mayo Clinic Rochester, Rochester, MN

Investigator: Lisa Boardman, MD

Site: Dana-Farber Cancer Institute, Boston, MA

Investigator: Ramona Lim, MD

Site: University of Colorado, Aurora, CO

Investigator: Swati G. Patel, MD, MS

Site: Mayo Clinic at Arizona, Phoenix, AZ

Investigator: Niloy Jewel Samadder, MD, MSc, FRCPC

Site: University of Arizona Cancer Center, Tucson, AZ

Investigator: Aaron James Scott, MD

Site: University of Michigan, Ann Arbor, MI

Investigator: Elena Stoffel, MD, MPH

Site: University of California San Francisco Medical Center

Investigator: Aparajita Singh, MD, MPH

More Information: https://clinicaltrials.gov/ct2/show/NCT05419011

Additional Resources

Study Brochure 

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