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ColoSpect study


- candidate number21943
- NTR NumberNTR5315
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2015
- Secondary IDsNL48298.031.14 METC Number
- Public TitleColoSpect study
- Scientific TitleIn vivo identification of rectum and colon carcinoma during surgery using optical spectroscopy techniques
- ACRONYM
- hypothesisThe primary objective of this pilot study is to calculate the sensitivity and specificity for discriminating tumor and benign tissues in vivo in colorectal cancer patients based on optical spectroscopy measurements. The secondary objective of this study is to calculate the spectral differences between in vivo and ex vivo measurements and the difference in the biological parameters (i.e. blood, water and fat content and blood oxygenation) that are extracted from the spectral information.
- Healt Condition(s) or Problem(s) studiedColorectal cancer
- Inclusion criteria-Patients planned for elective colorectal surgery for either primary or recurrent colorectal cancer by an open or laparoscopic approach
- Patients planned for a HIPEC procedure for colorectal cancer
- Patients that have provided a signed informed consent
- Patients 18 years old
- Exclusion criteriaPatients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 3-apr-2015
- planned closingdate30-dec-2015
- Target number of participants47
- InterventionsObservation of surgical tissue by means of optical spectroscopy.
- Primary outcomeCalculation of the sensitivity and specificity for discriminating tumor and benign tissues in vivo in colorectal cancer patients based on optical spectroscopy measurements.
- Secondary outcomeCalculation of the spectral differences between in vivo and ex vivo measurements and the difference in the biological parameters (i.e. fat content, blood oxygenation, etc.) that are extracted from the spectral information.
- TimepointsOnly one measurement at day of surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Torre Bydlon
- CONTACT for SCIENTIFIC QUERIESDr. Torre Bydlon
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips, KWF Kankerbestrijding
- PublicationsNot applicable
- Brief summarySubjects recruited at Nederlands Kanker Instituut (NKI) in Amsterdam. Single study site.
Optical spectroscopy measurements of normal and malignant colorectal tissue and healthy surrounding tissues are performed during surgery. After surgery, spectroscopic measurements are repeated on the excised tissue. To compare the spectroscopic measurements to standard histopathology assessment, biopsies will be taken from the measured locations on the excised specimen. In vivo biopsies are taken of measurement locations on healthy tissue that cannot be resected with the tumor.
- Main changes (audit trail)
- RECORD13-apr-2015 - 24-aug-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl