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Liquid Biopsy in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926468
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Head and Neck Squamous Cell Carcinoma Diagnostic Test: Liquid biopsy

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Profiling by Liquid Biopsy for Initial Characterization and Response Monitoring of Head and Neck Squamous Cell Carcinoma (HNSCC)
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy


Intervention Details:
  • Diagnostic Test: Liquid biopsy
    Before onset of treatment, cell-free DNA (cfDNA) is extracted from venous blood sample for next-generation DNA sequencing (NGS) using a commercially available platform (Roche Foundation ACT) For this purpose, 4 x 10 ml of venous blood will be collected from each patient. Two tubes (Streck) will be sent to service provider (Roche), one tube will be used for droplet digital polymerase chain reaction (ddPCR, QX200 Droplet Digital PCR System, BioRad) and ddPRC/NGS analyses and one is collected and stored in Auria Biobank (www.auria.fi) for possible future analyses.


Primary Outcome Measures :
  1. Diagnostic performance of circulating tumor DNA (ctDNA) in venous blood sample: Baseline [ Time Frame: Baseline ]
    Measurement of ctDNA with a novel droplet digital polymerase chain reaction (ddPCR)

  2. Diagnostic performance of circulating tumor DNA (ctDNA) in venous blood sample: 3-month follow-up [ Time Frame: 3-months after completion of therapy (approximately 6 months post-baseline) ]
    Measurement of ctDNA with a novel droplet digital polymerase chain reaction


Biospecimen Retention:   Samples With DNA
Circulating tumor DNA (ctDNA) collected from venous blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed HNSCC referred to curative multimodality treatment in Hospital District of Southwest Finland
Criteria

Inclusion Criteria:

  • histologically confirmed head and neck squamous cell carcinoma (HNSCC)
  • WHO performance status 0-2
  • clinical stage III patients with bulky T3 primary +/- neck metastasis
  • all stage IV patients
  • referral to definitive radiotherapy or chemoradiotherapy or multimodality treatment

Exclusion Criteria:

  • patients who are not able to sign written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926468


Contacts
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Contact: Heikki Minn, Prof., MD +35823130000 ext 30149 heikki.minn@tyks.fi
Contact: Heikki Irjala, MD, PhD +35823130000 ext 30411 heikki.irjala@tyks.fi

Locations
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Finland
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Heikki RI Minn, Prof., MD Head, Department of Oncology and Radiotherapy
Publications:
Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03926468    
Other Study ID Numbers: T17/2019
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Turku University Hospital:
Liquid biopsy
FDG PET-CT
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site