Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2018-05-28
2022-12-31
Brief Summary
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The primary objective of this prospective study is to establish a prognostic marker of early disease progression after complete surgical resection in patients with stages I to IIIA NSCLC. For this purpose the investigator will compare the metabolic profile with disease progression or death within one year after complete surgical resection to the patients with a progression free survival. Furthermore the investigator will evaluate the changes in the metabolic profile after surgery and if changes in this metabolic profile over time can predict disease recurrence before it becomes clinically apparent.
Detailed Description
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Rationale: Complete resection is the mainstay of treatment for stage I-IIIA resectable non-small cell lung cancer (NSCLC). However rates of recurrence of disease are high, with five-year survival rates ranging between 73% (stage IA) and 24% (stage IIIA). Therefore, a prognostic biological marker that stratifies between NSCLC patients whom surgery cures versus patients in whom surgery would be futile due to early disease relapse after surgery is eagerly awaited.
Study objective: The primary study hypothesis is that the metabolic plasma profile is a predictive marker of early disease progression after complete surgical resection in patients with pathological stages I to IIIA NSCLC. The secondary study hypothesis is that the level of dissimilarity between the metabolic profile before surgery and the metabolic profile after surgery, is a predictor for disease recurrence (in which the extreme case would be, that a normalization of the metabolic profile to the profile of a healthy person, is indicative of a good prognosis).
Study design: Prospective, interventional design
Study population: Stage I-IIIA NSCLC patients who will undergo complete surgical resection willing to provide a written informed consent.
Number of patients: 200 patients with stage I-IIIA NSCLC who will undergo thoracic surgery with a curative intent will be included.
Main study parameters/endpoints: Recurrence free survival, overall survival, metabolic phenotype, presence or absence of hot-spot mutations in tested proto-oncogenes and tumor suppressor genes in circulating tumor DNA (ctDNA) in blood plasma, the tumor tissue and possibly positive lymph nodes, 43 items of the EORTC quality of life questionnaire C30 and LC13.
Nature and extent of the burden and risks associated with participation: Subjects will be asked to give consent to take 10-30 ml of blood at several moments throughout the disease course and in follow-up. Furthermore, the participants need to give their permission to use the resected tumor/lymph node tissue for genetic testing. Clinical parameters will be pooled in a database in a confidential way.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Additional blood sampling
non-small cell lung cancer (NSCLC)
Additional blood sampling
Establish predictive markers for early disease progression after complete surgical resection in patients with stage I to IIIA NSCLC.
Interventions
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Additional blood sampling
Establish predictive markers for early disease progression after complete surgical resection in patients with stage I to IIIA NSCLC.
Eligibility Criteria
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Inclusion Criteria
2. Signed written informed consent
Exclusion Criteria
2. Medication intake in the morning of the blood sampling
3. Non-controlled diabetes
4. History of cancer during the past 5 years
5. Treatment for cancer during the past 5 years
18 Years
ALL
No
Sponsors
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Ziekenhuis Oost-Limburg
OTHER
Hasselt University
OTHER
Responsible Party
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Prof. dr. Michiel Thomeer
Head of department of respiratory medicine
Principal Investigators
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Michiel Thomeer, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Elien Derveaux, drs.
Role: STUDY_CHAIR
Hasselt University
Liesbet Mesotten, prof. dr.
Role: STUDY_CHAIR
Hasselt University
peter Adriaensens, prof. dr.
Role: STUDY_CHAIR
Hasselt University
Locations
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OLV ziekenhuis Aalst
Aalst, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
UZ Gent
Ghent, , Belgium
AZ Delta
Roeselare, , Belgium
Countries
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References
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Louis E, Cantrelle FX, Mesotten L, Reekmans G, Bervoets L, Vanhove K, Thomeer M, Lippens G, Adriaensens P. Metabolic phenotyping of human plasma by 1 H-NMR at high and medium magnetic field strengths: a case study for lung cancer. Magn Reson Chem. 2017 Aug;55(8):706-713. doi: 10.1002/mrc.4577. Epub 2017 Feb 27.
Beger RD, Dunn W, Schmidt MA, Gross SS, Kirwan JA, Cascante M, Brennan L, Wishart DS, Oresic M, Hankemeier T, Broadhurst DI, Lane AN, Suhre K, Kastenmuller G, Sumner SJ, Thiele I, Fiehn O, Kaddurah-Daouk R; for "Precision Medicine and Pharmacometabolomics Task Group"-Metabolomics Society Initiative. Metabolomics enables precision medicine: "A White Paper, Community Perspective". Metabolomics. 2016;12(10):149. doi: 10.1007/s11306-016-1094-6. Epub 2016 Sep 2.
Beger RD. A review of applications of metabolomics in cancer. Metabolites. 2013 Jul 5;3(3):552-74. doi: 10.3390/metabo3030552.
Louis E, Adriaensens P, Guedens W, Bigirumurame T, Baeten K, Vanhove K, Vandeurzen K, Darquennes K, Vansteenkiste J, Dooms C, Shkedy Z, Mesotten L, Thomeer M. Detection of Lung Cancer through Metabolic Changes Measured in Blood Plasma. J Thorac Oncol. 2016 Apr;11(4):516-23. doi: 10.1016/j.jtho.2016.01.011. Epub 2016 Feb 29.
Louis E, Adriaensens P, Guedens W, Vanhove K, Vandeurzen K, Darquennes K, Vansteenkiste J, Dooms C, de Jonge E, Thomeer M, Mesotten L. Metabolic phenotyping of human blood plasma: a powerful tool to discriminate between cancer types? Ann Oncol. 2016 Jan;27(1):178-84. doi: 10.1093/annonc/mdv499. Epub 2015 Oct 20.
Other Identifiers
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PROLUNG001
Identifier Type: -
Identifier Source: org_study_id