Colorectal Cancer Clinical Trial
Official title:
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.
Primary Objectives: - To evaluate the effect of naproxen or aspirin on the abundance of T cells and other im-mune cell types in the normal colorectal mucosa of participants with Lynch syndrome (LS) using single-cell approaches. Secondary Objectives: - To evaluate cell-type specific effects of treatment with naproxen or aspirin on gene ex-pression in the normal colorectal mucosa and endometrium in participants with LS using single-cell approaches. - To evaluate the effect of treatment with naproxen or aspirin on the spatial distribution of immune-related cell types in the normal colorectal mucosa and endometrium in of partic-ipants with LS using multiplex imaging approaches. - To assess the effect of treatment with naproxen or aspirin on colorectal polyp burden in participants with LS. - To assess the safety profile of treatment with naproxen or aspirin in participants with LS. - To assess the effect of treatment with naproxen or aspirin in normal mucosa, stool and periodontal microbiome in participants with LS. - To compare the effect of naproxen or aspirin on the abundance of T cells and other im-mune cell types in the normal colorectal mucosa, endometrium and peripheral blood of participants with LS. - To assess the symptoms of LS participants randomized to naproxen or aspirin. ;
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