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Electronic nose for breath analysis after curative Surgery to detect distant metastases or locoregional recurrence of colon cancer

Electronic nose for breath analysis after curative Surgery to detect distant metastases or locoregional recurrence of colon cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22434
Enrollment
1184
Registered
2020-11-23
Start date
2020-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing curative treatment for CRC

Interventions

Patients are given a breath test during the first three years of follow-up if they come for a regular follow-up with imaging. If verification of only CEA determination (year 4 and 5) gives rise to ima

Sponsors

• The ‘Medisch Specialistisch Bedrijf’(MSB) of Isala has invested in The eNose Company, Zutphen, The Netherlands. The researchers have received a grant from the Innovation & Science fund Isala. • The eNose Company invests by making the eNose devices, disposable mouthpieces and analysis of the breath tests available.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Follow-up patients with an intentional curative treatment of CRC stage I to IV • a CRC treated with curative intent by means of a colorectal resection • curative treatment of synchronous metastases in combination with colorectal resection • curatively treated metachronous metastases, after colorectal resection 2. Age = 18 years.

Exclusion criteria

Exclusion criteria: 1. Not proficient in Dutch 2. Reason to believe that the patient cannot perform a breath test 3. CRC not treated curatively 4. CRC pT1N0Mx / pT1NxMx (patients receiving endoscopic control only) 5. Local (surgical or endoscopic) resection 6. Active treatment of other malignancies within the past three months

Design outcomes

Primary

MeasureTime frame
the diagnostic accuracy of eNose in the detection of recurrent CRC

Contacts

Public ContactIvonne Schoenaker

Isala

i.j.h.schoenaker@isala.nl0031 38 424 8293

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)