Metabolomics Predict Therapy Response

NCT03736993 | Completed

• 1 other identifier: PROLUNG001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief Summary

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. 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.

Conditions

NSCLC, Stage IIIA

Outcome Measures

Primary Outcomes (1)

• The metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR)

  The metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR) spectroscopy predicts disease disease recurrence within one year after surgical resection.

  baseline

Secondary Outcomes (4)

• Change in the metabolic profile in plasma measured by Nuclear Magnetic Resonance (NMR)

  screening, day 1, week 1, week 4, week 6, week 12, week 52

• Change in ctDNA mutations in plasma

  day 1, week 12, week 52

• Correlation between presence or absence Hotspot mutations and the metabolic profile in plasma

  day 1, week 12, week 52

• Metabolic profile of the primary tumor

  day 1

Study Arms (1)

Additional blood sampling

OTHER

non-small cell lung cancer (NSCLC)

Other: Additional blood sampling

Interventions

Additional blood sampling OTHER

Establish predictive markers for early disease progression after complete surgical resection in patients with stage I to IIIA NSCLC.

Additional blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a stage I-IIIA NSCLC tumor, eligible to undergo surgery
• Signed written informed consent

You may not qualify if:

• No fasting starting from 22:00 h the day prior to blood sampling
• Medication intake in the morning of the blood sampling
• Non-controlled diabetes
• History of cancer during the past 5 years
• Treatment for cancer during the past 5 years

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (4)

OLV ziekenhuis Aalst

Aalst, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Related Publications (5)

• 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.

  PMID: 28061019 BACKGROUND

• 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.

  PMID: 27642271 BACKGROUND

• Beger RD. A review of applications of metabolomics in cancer. Metabolites. 2013 Jul 5;3(3):552-74. doi: 10.3390/metabo3030552.

  PMID: 24958139 BACKGROUND

• 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.

  PMID: 26949046 RESULT

• 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.

  PMID: 26487580 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michiel Thomeer, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Elien Derveaux, drs.

  Hasselt University

  STUDY CHAIR

• Liesbet Mesotten, prof. dr.

  Hasselt University

  STUDY CHAIR

• peter Adriaensens, prof. dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of respiratory medicine

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: November 9, 2018
• Study Start: May 28, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

BE (4)