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

S

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)

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

Trial contacts and locations

1

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Central trial contact

HAREL HERSHTIK

Data sourced from clinicaltrials.gov

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