Matching tumor and blood gene tests for HPV-negative head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study that collects blood samples and compares gene expression patterns in blood with those found in matched primary tumor tissue from people with HPV-negative squamous head and neck cancers. Participants give a blood sample before starting curative-intent treatment and another about three months after finishing treatment while they receive standard care from their own clinical team. Researchers will analyze whether blood-based gene signatures correspond to tumor subtypes and whether those signatures relate to clinical outcomes. The study is conducted at specialized cancer centers in Italy and enrolls patients with stage III–IVa/b, non-metastatic, p16/HPV-negative primary tumors of selected head and neck sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologic diagnosis of HNSCC
* Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx
* Stage III-IVa/b according to the eighth edition of AJCC/UICC classification
* Treatment with curative intent
* Unequivocal clinical and/or radiological absence of metastatic disease
* Patient ability and availability to comply with study protocol procedures.-

Exclusion Criteria:

* Recurrent/metastatic HNSCC
* p16+ oropharyngeal squamous cell carcinoma
* Evidence of high-risk HPV infection at tumor level
* Cancer of unknown primary site
* Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers)
* Skin squamous cell carcinoma from the skin of the head and neck
* Nasopharyngeal carcinoma
* Sinonasal/paranasal cancers
* Insufficient data about previous medical history.

Where it's running

• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Italy Recruiting
• Azienda Ospedaliera Universitaria di Sassari
  Sassari, Italy Recruiting

Study contacts

• Principal investigator: Lisa Licitra — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Study coordinator: Lisa Licitra
• Email: lisa.licitra@istitutotumori.mi.it
• Phone: +39 02 2390 2810

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

  This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

  Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

• Hyperfractionated radiotherapy vs high-dose cisplatin-based chemoradiation for head and neck cancer

  This trial tests whether giving hyperfractionated radiation therapy is as effective as high-dose cisplatin with radiation for people with head and neck squamous cell carcinoma.

  Recruiting King Hussein Cancer Center · Amman · NCT07801235

• GI-108 monotherapy for people with advanced or metastatic solid tumors

  We are testing GI-108 by itself to see if it is safe and can shrink tumors in people with advanced or metastatic solid tumors, including lung, head and neck, and pancreatic cancers.

  Recruiting at 3 sites Phase 1/2 GI Innovation, Inc. · Seoul and 2 other locations · NCT07172802

• CP-383 for advanced or metastatic solid tumors

  This trial tests whether the oral drug CP-383 can slow or stop growth in adults with advanced or metastatic solid tumors who have exhausted standard treatments.

  Recruiting at 13 sites Phase 1/2 Tasca Therapeutics · Denver, Colorado and 12 other locations · NCT07030257

• Triple-drug neoadjuvant therapy for EGFR-positive locally advanced head and neck cancer

  This trial tests a three-drug neoadjuvant regimen (Becotatug Vedotin, Pucotenlimab, and Cisplatin) in adults with EGFR-positive, locally advanced head and neck cancer to see if it can shrink tumors before surgery or chemoradiotherapy.

  Recruiting at 2 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT07814287

• CCR2 PET Imaging for Head and Neck Squamous Cell Carcinoma

  This trial tests whether Cu-64 DOTA-ECL1i PET/CT can reliably detect HNSCC in adults, including those with new locally advanced disease or suspected/confirmed recurrent/metastatic cancer.

  Recruiting Phase 2 Washington University School of Medicine · St Louis, Missouri · NCT07659678

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.