Chemical Profiling of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study

Scentech Medical Technologies

Status: Not yet enrolling

Conditions: Pancreatic Cancer; Colorectal Cancer

Treatments: Diagnostic Test: VOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05400408

CRCPC-SMC-2021

Details and patient eligibility

About

Detection of Colorectal and Pancreatic Cancers Using Breath Analysis - Feasibility Study

Full description

A diagnostic prospective study with no anticipated risks or constraints. Main Objective: To quantify differences in exhaled breath VOCs of patients with colorectal or pancreatic cancers compared with cohorts without cancer.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 to 85 years at the time of consent.
• Scheduled for colonoscopy or Endoscopic Retrograde Cholangio Pancreatography.
• Fasted >6 hours, consuming water only.
• Able to provide informed written consent.

Exclusion criteria

• Lacks capacity or is unable to provide informed written consent.
• Pregnant or lactating woman.
• Histologically confirmed cancer in any organ.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Colorectal Cancer

Experimental group

Description:

Subjects who were diagnosed as Colorectal Cancer patients by colonoscopy.

Treatment:

Diagnostic Test: VOX

Pancreatic Cancer

Experimental group

Description:

Subjects who were diagnosed as Pancreatic Cancer patients by Endoscopic Retrograde Cholangio Pancreatography.

Treatment:

Diagnostic Test: VOX

Healthy volunteers

Other group

Description:

Subjects who were found with no Colorectal or Pancreatic malignancies, by either colonoscopy or by Endoscopic Retrograde Cholangio Pancreatography.

Treatment:

Diagnostic Test: VOX