Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 10:21 AM
Study NCT ID:
NCT04216251
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2019-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PRevention Using EPA Against coloREctal Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
PREPARE: PRevention Using EPA Against coloREctal Cancer
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPARE
Brief Summary:
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).
\- The name of the study drug involved in this study is:
\-- AMR101 (VASCEPA).
Detailed Description:
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: