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ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial.
Drew, David A; Chin, Samantha M; Gilpin, Katherine K; Parziale, Melanie; Pond, Emily; Schuck, Madeline M; Stewart, Kathleen; Flagg, Meaghan; Rawlings, Crystal A; Backman, Vadim; Carolan, Peter J; Chung, Daniel C; Colizzo, Francis P; Freedman, Matthew; Gala, Manish; Garber, John J; Huttenhower, Curtis; Kedrin, Dmitriy; Khalili, Hamed; Kwon, Douglas S; Markowitz, Sanford D; Milne, Ginger L; Nishioka, Norman S; Richter, James M; Roy, Hemant K; Staller, Kyle; Wang, Molin; Chan, Andrew T.
Afiliação
  • Drew DA; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Chin SM; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Gilpin KK; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Parziale M; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Pond E; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Schuck MM; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Stewart K; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Flagg M; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Rawlings CA; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Backman V; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Carolan PJ; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Chung DC; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Colizzo FP; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Freedman M; The Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.
  • Gala M; The Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.
  • Garber JJ; McCormick School of Engineering, Northwestern University, Evanston, IL, USA.
  • Huttenhower C; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Kedrin D; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Khalili H; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Kwon DS; Broad Institute, Cambridge, MA, USA.
  • Markowitz SD; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Milne GL; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Nishioka NS; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Richter JM; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
  • Roy HK; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Staller K; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Wang M; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • Chan AT; The Ragon Institute of MGH, MIT and Harvard, Cambridge, MA, USA.
Trials ; 18(1): 50, 2017 02 01.
Article em En | MEDLINE | ID: mdl-28143522
ABSTRACT

BACKGROUND:

Although aspirin is recommended for the prevention of colorectal cancer, the specific individuals for whom the benefits outweigh the risks are not clearly defined. Moreover, the precise mechanisms by which aspirin reduces the risk of cancer are unclear. We recently launched the ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED) trial to address these uncertainties. METHODS/

DESIGN:

ASPIRED is a prospective, double-blind, multidose, placebo-controlled, biomarker clinical trial of aspirin use in individuals previously diagnosed with colorectal adenoma. Individuals (n = 180) will be randomized in a 111 ratio to low-dose (81 mg/day) or standard-dose (325 mg/day) aspirin or placebo. At two study visits, participants will provide lifestyle, dietary and biometric data in addition to urine, saliva and blood specimens. Stool, grossly normal colorectal mucosal biopsies and cytology brushings will be collected during a flexible sigmoidoscopy without bowel preparation. The study will examine the effect of aspirin on urinary prostaglandin metabolites (PGE-M; primary endpoint), plasma inflammatory markers (macrophage inhibitory cytokine-1 (MIC-1)), colonic expression of transcription factor binding (transcription factor 7-like 2 (TCF7L2)), colonocyte gene expression, including hydroxyprostaglandin dehydrogenase 15-(NAD) (HPGD) and those that encode Wnt signaling proteins, colonic cellular nanocytology and oral and gut microbial composition and function.

DISCUSSION:

Aspirin may prevent colorectal cancer through multiple, interrelated mechanisms. The ASPIRED trial will scrutinize these pathways and investigate putative mechanistically based risk-stratification biomarkers. TRIAL REGISTRATION This protocol is registered with the U.S. National Institutes of Health trial registry, ClinicalTrials.gov, under the identifier NCT02394769 . Registered on 16 March 2015.
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 / 2_ODS3 Base de dados: MEDLINE Assunto principal: Carcinoma / Neoplasias Colorretais / Adenoma / Aspirina / Anticarcinógenos Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged80 País/Região como assunto: America do norte Idioma: En Revista: Trials Ano de publicação: 2017 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 / 2_ODS3 Base de dados: MEDLINE Assunto principal: Carcinoma / Neoplasias Colorretais / Adenoma / Aspirina / Anticarcinógenos Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged80 País/Região como assunto: America do norte Idioma: En Revista: Trials Ano de publicação: 2017 Tipo de documento: Article