Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening

Overview

Información sobre este estudio

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Subject is male or female.
  • 40 years of age or older. 
  • Subject is at average or increased risk for development of colorectal cancer (CRC). 
  • Subject presents for screening or surveillance colonoscopy. 
  • Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. 
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria: 

  • Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years. 
  • Subject has a diagnosis or personal history of any of the following conditions, including:
    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome). 
    • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). 
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.
  • Subject has a family history of: 
    • Familial adenomatous polyposis (also referred to as "FAP"). 
    • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). 
  • Subjects with Cronkhite-Canada Syndrome. 
  • IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection. 
  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

John Kisiel, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20467635

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