NCT03926468

Liquid Biopsy in Head and Neck Cancer

Status unknown Last updated 4 June 2019

What this trial tests

trial testing Liquid biopsy in Head and Neck Squamous Cell Carcinoma in 30 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
30 June 2022

31 December 2022

Quick facts

Lead sponsor	Turku University Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 August 2019
Primary completion	30 June 2022
Estimated completion	31 December 2022
Sites	1 location across Finland

Drugs / interventions tested

• Liquid biopsy — full drug profile →

Conditions studied

• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

Turku University Hospital

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Overall survival of patients with head and neck squamous cell carcinoma (HNSCC) remains unsatisfactory due to often advanced clinical stage at diagnosis and high rate of recurrence and second primaries. About 75 % of patients with localized HNSCC are expected to show circulating tumor DNA (ctDNA) pre-treatment. ctDNA reflects tumor genome and disease burden and is termed 'liquid biopsy' (LB) when collected through venous bloodstream. LB has potential to assist in early diagnosis of recurrence and progression, and prediction of response to targeted therapeutic agents. Increased metabolic activity measured in positron emission tomography-computed tomography (PET-CT) is currently the most sensitive technique to detect residual cancer or progression of HNSCC after curative treatment. High metabolically active tumor volume (MTV) is associated with treatment resistance and shows independent prognostic significance. The objective is (i) to investigate whether MTV detected with PET-CT correlates to the pattern and amount of genetic alterations in ctDNA of patients with HNSCC referred to radio- (chemo)therapy (RT/CRT). Another objective is (ii) to determine sensitivity of LB compared to PET/CT in detecting residual tumor 3 months after completion of RT/CRT. Third (iii), genetic landscape in LB and fresh tumor samples will be evaluated to detect resistance genes and targets for immunotherapy and surveillance post-treatment. This prospective study includes 30 patients with stage III/IV HNSCC. Before onset and 3 months from RT/CRT, LB is obtained for next-generation DNA sequencing using a commercial platform. ctDNA and digital droplet PCR will be quantified and compared to MTV in simultaneously acquired PET-CT. The investigators hypothesize that LB could assist or replace PET/CT in response monitoring and detection of recurrence after RT/CRT.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Circulating Tumor DNA in Head and Neck Squamous Cell Carcinoma: Association with Metabolic Tumor Burden Determined with FDG-PET/CT.
   Silvoniemi A, Laine J, Aro K, Nissi L, et al · · 2023 · cited 18× · PMID 37568786 · DOI 10.3390/cancers15153970
2. The Role of ctDNA and Liquid Biopsy in the Diagnosis and Monitoring of Head and Neck Cancer: Towards Precision Medicine.
   Nassar SI, Suk A, Nguyen SA, Adilbay D, et al · · 2024 · cited 11× · PMID 39335101 · DOI 10.3390/cancers16183129
3. Prognostic and Predictive Biomarkers in Head and Neck Squamous Cell Carcinoma Treated with Radiotherapy-A Systematic Review.
   Schanne DH, Koch A, Elicin O, Giger R, et al · · 2022 · cited 6× · PMID 36552043 · DOI 10.3390/biomedicines10123288
4. The Value of Circulating Tumor HPV DNA in Head and Neck Squamous Cell Cancer: A Review.
   Dok R, Nuyts S, Lopez F, Bradford C, et al · · 2025 · PMID 41226001 · DOI 10.3390/diagnostics15212708