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SCENT 1. Differences in smellprints between patients with lung cancer and breast cancer.


- candidate number4812
- NTR NumberNTR1604
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2008
- Secondary IDs579 TPO
- Public TitleSCENT 1. Differences in smellprints between patients with lung cancer and breast cancer.
- Scientific TitleSmellprints in lung Cancer; the role of ENose in diagnosis and Treatment (SCENT): part 1. Differences in smellprints between patients with lung cancer and breast cancer.
- ACRONYMSCENT study
- hypothesisWe hypothesize that an electronic nose can discriminate the VOC pattern in exhaled breath between patients with non small cell lung cancer (NSCLC) and breast cancer.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Lung cancer
- Inclusion criteriaWritten informed consent obtained.

Lung cancer patients:
1. Adults 18-80 years;
2. Non small cell lung cancer (NSCLC).

Lung cancer controls:
1. Adults 18-80 years;
2. Matched for:
a. Age: age<50 yr, 50 b. Smoking status: current smoker or ex-smoker<3 months, ex-smoker>3 months.
c. Sex.

Breast cancer patients:
1. Women 18-80 years;
2. Breast cancer.

Breast cancer controls:
1. Women 18-80 years;
2. Matched for:
a. Age: age<50 yr, 50≤age≤70, 70 b. Smoking status: current smoker or ex-smoker<3 months, ex-smoker>3 months.
- Exclusion criteria1. Other known pulmonary diseases;
2. Other or former malignancy;
3. Pregnancy;
4. Diabetes mellitus (documented in the past);
5. Hypercholesterolaemia (documented in the past);
6. Significant cardiovascular disease;
7. Any infection (especially of the airways) in the last 4 weeks;
8. Paradontitis.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 2-jan-2009
- planned closingdate31-dec-2011
- Target number of participants100
- InterventionsN/A
- Primary outcome(Difference) in smell-prints between patients with lung cancer AND breast cancer.
- Secondary outcome1. Difference in smell-prints between patients with breast cancer and controls;
2. Difference in smell-prints between patients with lung cancer and controls;
3. Difference in smellprints between patients before and twice after resection of the lung tumour (at 1 and 6 week post-resection).
- TimepointsBaseline measurement when they are seen for the first time at the outpatient department. In case of resection of tumor 2 and 6 weeks post-operative also a measurement.
- 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 summaryIn the present study we will examine the difference in VOC pattern of exhaled air between patients with histology-confirmed diagnoses of non small cell lung cancer vs breast cancer.
As secondary aims, we intend to confirm the potential of the electronic nose to distinguish the VOC patterns between patients with NSCLC and healthy controls and to assess its capacity to discriminate between women with and without breast cancer. We also aim to investigate whether the VOC pattern changes when resection of the lung cancer has been performed.
Finally, when the eNose demonstrates to be capable to distinguish the VOC patterns of patients with NSCLC and breast cancer, we will try to identify the distinct biomarkers in the exhaled breath samples of both groups by using gaschromatography and mass spectrometry (GC MS).

Study design:
Cross-sectional case-control study.
Patient recruitment on base of intention to diagnose: See study population.

At the Pulmonary Function Department each participant will follow this sequence:
1. Questionnaire;
2. Exhaled breath collection;
3. Spirometry.

Study population:
1. All women (18-80 yr) suspected of having breast cancer, referred to the OPD specialised in the diagnostic work-up of breast abnormalities in our hospital (ˇ°mamma poliˇ±) will be asked to participate (intention-to-diagnose). 25 patients with histologically confirmed breast cancer without significant co-morbidity will be included in the analysis of the present study.
2. All patients (18-80 yr) suspected of having lung cancer, referred to the pulmonary OPD in our hospital will be asked to participate (intention-to-diagnose). 25 patients with histologically confirmed non-small cell lung cancer without significant co-morbidity will be included in the analysis of the present study.
3. 25 women without breast cancer, matched with breast cancer patients (above) for age and smoking history without significant co-morbidity, will be selected from the intention-to-diagnose cohort.
4. 25 healthy controls, matched with the NSCLC patients (above) for sex, age, and smoking history, will be recruited from visitors and personnel of our hospital, of course on voluntary base.
- Main changes (audit trail)
- RECORD29-dec-2008 - 6-mei-2011


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