A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma

Summary

The goal of this observational study is to better understand why some people with metastatic adenoid cystic carcinoma (ACC) of the head and neck have slow-growing disease while others have faster-growing or more aggressive disease. Researchers want to learn how the biology of the tumor relates to each person's clinical risk group, which is based on a published prediction tool (a nomogram).

The main question the study aims to answer is: Do people in the high-risk and low-risk groups have different biological tumor types (called ACC-I and ACC-II) when their primary tumor is tested?

The study will also look at other important questions, such as:

* Do metastatic tumors show the same biological type as the original tumor?
* Do biological types differ based on where metastases grow or how early or late they appear?
* Are biological types linked to how well systemic treatments work?
* Can blood tests (including DNA fragments or small RNA molecules in the blood) show the same tumor biology and help track how the cancer changes over time?

Participants will:

* Allow researchers to study samples of tumor tissue taken in the past during standard care.
* Give blood samples at study entry and then every 6 months for up to 2 years.
* Continue all medical treatments and follow-up visits as decided by their own care team.
* Receive no study treatment; this study only collects information and samples.

About 114 adults with metastatic ACC of the head and neck will join the study. People with only local or regional recurrence (without metastases) or those whose primary tumor started outside the head and neck cannot take part.

The information gathered may help researchers understand why ACC behaves differently from person to person, identify new biological markers in blood, and support future personalized treatment strategies for people with metastatic ACC.

Conditions

• Adenoid Cystic Carcinoma of the Salivary Gland
• Adenoid Cystic Carcinoma of the Head and Neck

Interventions

OTHER

Standard of Care (Investigator Choice)

This study does not include any medical treatment or experimental therapy. The only study-specific procedures are the collection and analysis of biological samples. The intervention consists of: * Use of stored tumor tissue collected previously as part of standard medical care. * At least two blood draws: one at study entry, one before the start of routine cancer treatment and one after 6 months. * Laboratory analyses of these samples to study gene activity, DNA fragments, DNA methylation, and circulating microRNAs. * Digital analysis of tumor slides using computer-based tools to identify biological patterns. These procedures are used only to compare blood-based markers with tumor-based markers. They do not change or influence the participant's medical treatment, which is decided entirely by their usual care team.

Sponsors & Collaborators

• Azienda Ospedaliera Brotzu

  collaborator OTHER

• Istituto Oncologico Veneto I.O.V. - I.R.C.C.S.

  collaborator UNKNOWN

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  collaborator NETWORK

• Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

  collaborator UNKNOWN

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  collaborator OTHER

• S. Orsola-Malpighi Hospital, University of Bologna

  collaborator UNKNOWN

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Lisa Licitra · Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2028-04-30

Completion

2028-12-31

Countries

• Italy

Study Locations