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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45168

Enrollment

1190

Registered

2013-12-03

Start date

2013-09-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer non-small cell lung cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Unwillingness to participate in study

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results