PRevention Using EPA Against coloREctal Cancer (PREPARE)
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|ClinicalTrials.gov Identifier: NCT04216251|
Recruitment Status : Active, not recruiting
First Posted : January 2, 2020
Last Update Posted : June 12, 2020
This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
- The name of the study drug involved in this study is:
-- AMR101 (VASCEPA).
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenoma Colorectal Cancer Endoscopic Surgery Eicosapentaenoic Acid Gastrointestinal Microbiome||Drug: AMR101||Phase 1 Phase 2|
This prospective, single-arm, research study evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.
- AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body.
- The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for any disease.
- AMR101 is commercially available in the US as VASCEPA (icosapent ethyl)
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, including:
- Lifestyle questionnaire,
- Nutritional survey
- Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)
- Blood samples,
- AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PREPARE: PRevention Using EPA Against coloREctal Cancer|
|Actual Study Start Date :||March 19, 2020|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Study procedures include screening for eligibility and study treatment including ARM101 Lifestyle questionnaire, Nutritional survey. Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample),blood, evaluations, and follow up visits.
- AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
Other Name: VASCEPA
- The change in the marine omega-3 polyunsaturated fatty acid (MO3PUFA) composition in colorectal tissues as a result of the AMR101 treatment for at least 28 days. [ Time Frame: 2 years after study completion ]The effect of daily 4-gram AMR101 treatment on MO3PUFA composition in colorectal tissue will be measured through the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
- The change in the gut microbiome composition and function between pre- and post- AMR101 treatment period. [ Time Frame: 2 years after study completion ]Metagenomic and metatranscriptomic sequencing of microbial DNA and RNA on pre- and post-treatment stool samples will be performed to examine the biomolecular mechanisms by which gut microbial activity may be altered or respond to AMR101 treatment.
- The change in stool metabolomics between pre- and post- AMR101 treatment period. [ Time Frame: 2 years after study completion ]Non-targeted global metabolomics and lipidomics analysis on pre- and post-treatment stool samples will be performed to examine the changes in the stool metabolite profile as a result of the AMR101 treatment.
- The change in gene expression profile of colorectal tissue between pre- and post- AMR101 treatment period. [ Time Frame: 2 years after study completion ]RNA-seq analysis to profile gene expression in the mucosal tissue collected before and after AMR101 treatment will be performed to examine whether the AMR101 treatment reduces the gene expression of inflammatory cytokines, chemokines (e.g., TNFα, IL6 and CCL2), and immunosuppressive factors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216251
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Mingyang Song, MD||Massachusetts General Hospital|