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SCENT part 2. Identification of patients with lung cancer and breast cancer.


- candidate number4829
- NTR NumberNTR1606
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2008
- Secondary IDs588 TPO
- Public TitleSCENT part 2. Identification of patients with lung cancer and breast cancer.
- Scientific TitleSmellprints in lung Cancer; the role of ENose in diagnosis and Treatment (SCENT): part 2. Identification of patients with lung cancer and breast cancer.
- ACRONYMSCENT
- hypothesisWe will test the hypothesis that smellprints can identify and classify newly presented patients prospectively into the categories of non small cell lung cancer (NSCLC) and breast cancer.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Lung cancer
- Inclusion criteriaAll patients (18-80 yr) referred to the outpatient department pulmonary diseases for suspicion of lung cancer and at the outpatient department of surgery for suspicion of breast cancer.
- Exclusion criteriaNone, exept impossibillity to make a diagnosis or folow the instructions prior to the measurement.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 2-jan-2009
- planned closingdate31-dec-2010
- Target number of participants300
- InterventionsN/A
- Primary outcomeSensitivity, specificity, positive and negative predictive value of the eNose in detecting NSCLC or breast cancer.
- Secondary outcomeSensitivity, specificity, positive and negative predictive value of the eNose in detecting subtypes of NSCLC (adenocarcinoma or squamous cell carcinoma)
- TimepointsBaseline measurement before histologic diagnosis is made.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES J. Maten, van der
- CONTACT for SCIENTIFIC QUERIES J. Maten, van der
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Leeuwarden
- PublicationsN/A
- Brief summaryOn the condition that such a discriminating algorithm can be deduced from the results of part 1, in part 2 of the SCENT study we will test the hypothesis that smellprints can identify and classify newly presented patients prospectively into the categories of non small cell lung cancer (NSCLC) and breast cancer.

Objective:
a. To determine the diagnostic accuracy of the electronic nose in establishing the sensitivity, specificity, positive and negative predictive value for detecting non small cell lung cancer in prospectively enrolled subjects (based on intention to diagnose in clinical practice);
b. To determine the diagnostic accuracy of the electronic nose in establishing the sensitivity, specificity, positive and negative predictive value for detecting breast cancer in prospectively enrolled subjects (based on intention to diagnose in clinical practice).


Study design:
diagnostic study.
This comprises prospective enrolment of new patients with an ‘intention to diagnose’ in order to determine the diagnostic accuracy of the electronic nose in the identification of NSCLC or breast cancer.

Study population:
All patients (18-80 yr) referred to the outpatient department pulmonary diseases for suspicion of lung cancer and at the outpatient department of surgery for suspicion of breast cancer.

Main study parameters/endpoints:
Sensitivity, specificity, positive and negative predictive value of the eNose in detecting NSCLC or breast cancer.
- Main changes (audit trail)
- RECORD29-dec-2008 - 6-mei-2011


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