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

NCT07507578 | Recruiting

• 1 other identifier: INT156-24
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Biology behind the nomogram-based classes of metastatic H&N ACC by assessing the relationship between the two clinical nomogram-based classes (high- vs. low-risk) and the proteogenomic subtype classification (ACC-I vs. ACC-II) in primary tumors

  The frequency of cases with ACC-I and ACC-II (proteogenomic subtype classification assessed in primary tumor specimens) in high- vs. low-risk (clinical nomogram-based) metastatic ACC patients.

  24 months

Secondary Outcomes (3)

• To assess if the proteogenomic subtype described in primary tumors is found in distant metastases

  24 months

• To assess if the proteogenomic subtypes in primary tumors reflect the spatio-temporal tumor biology heterogeneity (primary tumor vs. distant metastases; lung vs. non-lung metastases; early vs. late metastases)

  24 months

• To assess if the proteogenomic subtype found in primary tumor is associated to objective response to systemic therapy.

  24 months

Other Outcomes (7)

• To assess if circulating epigenomic biomarkers (e.g., ct-miRNA; ctDNA-based DNA methylation) are detectable in metastatic ACC patients

  24 months

• To assess if the biological profile of tumor specimens can be translated on circulating blood

  24 months

• To assess if the biological profile of primary tumor can be translated on circulating blood

  24 months

Interventions

Standard of Care (Investigator Choice) OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Metastatic adenoid cystic carcinoma of head and neck

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• 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
• S. Orsola-Malpighi Hospital, University of Bologna: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The study will keep: * Tumor tissue samples collected during standard medical care. These include stored formalin-fixed, paraffin-embedded (FFPE) tumor blocks or slides. * Blood samples collected at two time points: before treatment and about 3 months after treatment. Blood will be processed to obtain plasma and other blood components for molecular testing. From these samples, researchers may analyze: * Genetic activity (gene expression) * DNA fragments and DNA methylation patterns * Circulating tumor DNA * Circulating microRNAs * Digital images of tumor tissue No additional procedures beyond routine tumor collection and two small blood draws are required to obtain these samples.

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lisa Licitra

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Licitra

CONTACT

+39 02 2390 2810; lisa.licitra@istitutotumori.mi.it

Stefano Cavalieri

CONTACT

stefano.cavalieri@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

IT (1)