Fluid phase biopsy (circulating tumour DNA and serum tumour markers) in patients with non-small cell lung cancer.

• Conditions: lung cancer; non-small cell lung cancer; 10038666

• Registration Number: NL-OMON45168
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 1190

Inclusion Criteria

Inclusion criteria locally advanced stage disease (for both stage 1-2):
1. 18 years of age, or above
2. Histologically or cytologically confirmed diagnosis of NSCLC
3. Stage II/III non-operable disease, without malignant pleural effusion
4. Indication for concurrent chemoradiotherapy (NKI-AVL: 66Gy in 24 fractions with daily
low dose cisplatin 6mg/m2; University Hospital Leuven: 66Gy in 33 fractions with 3 weekly dose cisplatin 75mg/m2)
5. Performance score: WHO 0-2 at study entry
6. Signed written informed consent;Inclusion criteria advanced stage NSCLC
1. 18 years of age, or above
2. Histologically or cytologically confirmed diagnosis of NSCLC
3. Advanced stage disease
4. Indication for treatment
5. Performance score: WHO 0-2 at study entry
6. Signed written informed consent

Exclusion Criteria

Unwillingness to participate in study

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint - advanced NSCLC & first study stage in locally advanced NSCLC:<br /><br>• Levels of ctDNA, in amplifiable copies per millilitre of plasma, determined<br /><br>before start of treatment, at multiple days during and after treatment<br /><br><br /><br>Primary endpoint - second study stage in locally advanced NSCLC:<br /><br>• Association of ctDNA levels with progression free survival at one year </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Percentage of patients with detectable ctDNA levels in plasma<br /><br>• Type and frequency of mutated genes in ctDNA found<br /><br>• Association of STMs levels with progression free survival at one year<br /><br>• Correlation of levels of ctDNA and STMs with locoregional and distant control<br /><br>• Correlation of levels of ctDNA and STMs with tumour burden<br /><br>o As assessed by gross tumour volume (GTV) before treatment<br /><br>o As assessed by response evaluation on CT-scan according to RECIST version1.112<br /><br>• Correlation of ctDNA kinetics with STMs kinetics</p><br>