Have you been diagnosed with Lynch Syndrome ?

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.

 

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.

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

Protocol and Site Principal Investigator: Ajay Bansal, MD

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

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

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Site: Northwestern University, Chicago, IL

Investigator: Charles Muller, MD

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Site: Cleveland Clinic, Cleveland, OH

Investigator: Carol Burke, MD

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

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

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Site: Ohio State University, Columbus, OH

Investigator: Peter Stanich, MD

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Site: Mayo Clinic Rochester, Rochester, MN

Investigator: Lisa Boardman, MD

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Site: Dana-Farber Cancer Institute, Boston, MA

Investigator: Ramona Lim, MD

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Site: University of Colorado, Aurora, CO

Investigator: Swati G. Patel, MD, MS

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Site: Mayo Clinic at Arizona, Phoenix, AZ

Investigator: Niloy Jewel Samadder, MD, MSc, FRCPC

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Site: University of Arizona Cancer Center, Tucson, AZ

Investigator: Aaron James Scott, MD

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Site: University of Michigan, Ann Arbor, MI

Investigator: Elena Stoffel, MD, MPH

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Site: University of California San Francisco Medical Center, San Francisco, CA

Investigator: Aparajita Singh, MD, MPH

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Site: NCI Clinical Center for Research NCICCR, Washington, DC

Investigator: Danielle Pastor, DO, PhD

 

Site: University of Chicago, Chicago, IL

Investigator: Sonia Kupfer, MD

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Site: City of Hope Comprehensive Cancer Center, Duarte, CA

Investigators: Gregory Idos, MD, MS; Joanne Jeter, MD, MS

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Site: Fox Chase Cancer Center, Philadelphia, PA

Investigator: Michael J Hall, MD, MS

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

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