Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

July 31, 2017

Study Completion Date

July 31, 2017

Conditions
Fecal Immunochemical Test
Interventions
DEVICE

FIT-SOC

Study subjects will be given a standard kit for fecal immunochemical test by their primary healthcare provider. As per standard practice, the patient will take the kit home and use the included FIT applicator to collect a stool sample from spontaneously passed stool during a regular bowel movement. The patient will then mail the stool sample to the lab in a pre-paid envelope, which is provided in the kit.

DEVICE

FIT-DRE

Study subjects will have a digital rectal exam completed by their primary care providers during the physical exam portion of a routine clinic visit. The stool collected on the examiner's finger will be applied to the FIT applicator in the standard kit, which will then be sent to the lab for processing.

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Boston Medical Center

OTHER