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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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.

Eligibility criteria

Qualifiers

Pathologic diagnosis of ACC

Primary ACC arising from the head and neck

Unequivocal clinical and/or radiological evidence of metastatic disease

Patient ability and availability to comply with study protocol procedures.

Disqualifiers

ACC patients with local and/or regional recurrence without distant metastases

Primary ACC arising from any non-head and neck region (e.g., breast, lung, skin etc)

Insufficient data about previous medical history.

Trial design

Treatments tested in this trial

  • Standard of Care (Investigator Choice)

Treatment groups

No treatment groups listed

Sponsors and collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Azienda Ospedaliera Brotzu

Collaborator

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

Collaborator

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Collaborator

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Collaborator

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

Collaborator

Malpighi Hospital, Bologna, Italy

Collaborator