Evidence map›Paper›PMID 37400806›Full record

ArticleBMC cancer2023

Prediction of residual disease using circulating DNA detection after potentiated radiotherapy for locally advanced head and neck cancer (NeckTAR): a study protocol for a prospective, multicentre trial.

Angeline Ginzac, Marie-Céleste Ferreira, Anne Cayre, Clément Bouvet, Julian Biau, Ioana Molnar, Nicolas Saroul, Nathalie Pham-Dang, Xavier Durando, Maureen Bernadach

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05710679 (Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05710679 narecruitingnot on this mapstarted 2024, after this paper: background citation

Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer

TypeinterventionalSponsorCentre Jean PerrinRan2024 to 2031Enrolled63ConditionsLocally Advanced Head and Neck CarcinomaArmsBlood sample
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Angeline GinzacDivision de Recherche Clinique, Clermont Auvergne University, INSERM, U1240, Molecular Imaging and Theranostic Strategies, Jean PERRIN Center, 58, Rue Montalembert, 63011, Clermont-Ferrand, France. angeline.ginzac@clermont.unicancer.fr.ORCID http://orcid.org/0000-0002-5614-0876
Marie-Céleste FerreiraOncoGènAuvergne Laboratory, Pathology Unit, Jean PERRIN Center, Clermont-Ferrand, 63011, France.
Anne CayreOncoGènAuvergne Laboratory, Pathology Unit, Jean PERRIN Center, Clermont-Ferrand, 63011, France.
Clément BouvetNuclear Medicine Department, Jean Perrin Center, Clermont Ferrand, 63011, France.
Julian BiauRadiotherapy department, Jean PERRIN Center, 63011, Clermont-Ferrand, France.ORCID http://orcid.org/0000-0002-1570-4487
Ioana MolnarDivision de Recherche Clinique, Clermont Auvergne University, INSERM, U1240, Molecular Imaging and Theranostic Strategies, Jean PERRIN Center, 58, Rue Montalembert, 63011, Clermont-Ferrand, France.ORCID http://orcid.org/0000-0001-5114-2648
Nicolas SaroulDepartment of Otorhinolaryngology - Head and Neck Surgery, Gabriel Montpied University Hospital Center, 63000, Clermont-Ferrand, France.
Nathalie Pham-DangDepartment of Maxillofacial and Plastic Surgery, Estaing University Hospital Center Clermont-Ferrand, 63000, Clermont-Ferrand, France.
Xavier DurandoDivision de Recherche Clinique, Clermont Auvergne University, INSERM, U1240, Molecular Imaging and Theranostic Strategies, Jean PERRIN Center, 58, Rue Montalembert, 63011, Clermont-Ferrand, France.ORCID http://orcid.org/0000-0001-6035-3172
Maureen BernadachClinical Research Division, Delegation for Clinical Research and Innovation, Jean PERRIN Center, 63011, Clermont-Ferrand, France.ORCID http://orcid.org/0000-0002-7185-0809
Centre Jean Perrin · FRInserm · FRUniversité Clermont Auvergne · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSensitive and reproducible detection of residual disease after treatment is a major challenge for patients with locally advanced head and neck cancer. Indeed, the current imaging techniques are not always reliable enough to determine the presence of residual disease. The aim of the NeckTAR trial is to assess the ability of circulating DNA (cDNA), both tumoral and viral, at three months post-treatment, to predict residual disease, at the time of the neck dissection, among patients with partial cervical lymph node response on PET-CT, after potentiated radiotherapy.

methodsThis will be an interventional, multicentre, single-arm, open-label, prospective study. A blood sample will be screened for cDNA before potentiated radiotherapy and after 3 months if adenomegaly persists on the CT scan 3 months after the end of treatment. Patients will be enrolled in 4 sites in France. Evaluable patients, i.e. those with presence of cDNA at inclusion, an indication for neck dissection, and a blood sample at M3, will be followed for 30 months. Thirty-two evaluable patients are expected to be recruited in the study. DISCUSSION: The decision to perform neck dissection in case of persistent cervical adenopathy after radio-chemotherapy for locally advanced head and neck cancer is not always straightforward. Although studies have shown that circulating tumour DNA is detectable in a large proportion of patients with head and neck cancer, enabling the monitoring of response, the current data is insufficient to allow routine use of this marker. Our study could lead to better identification of patients who do not have residual lymph node disease in order to avoid neck dissection and preserve their quality-of-life while maintaining their prospects of survival.

trial registrationClinicaltrials.gov: NCT05710679, registered on 02/02/2023, https://clinicaltrials.gov/ct2/show/ . Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°ID RCB 2022-A01668-35, registered on July 15

Indexed as

Carcinoma, Squamous CellCell-Free Nucleic AcidsHead and Neck NeoplasmsDNA, ComplementaryHumansMulticenter Studies as TopicPositron Emission Tomography Computed TomographyProspective StudiesCell-Free Nucleic AcidsDNA, ComplementaryCirculating DNAHead and neck cancerHPV-HRPotentiated radiotherapyResidual disease

Identifiers

PMID37400806
PMCPMC10318756
OpenAlexW4383058579

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.