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NCT Number: NCT07507578

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location status: Recruiting

Location contact

Lisa Licitra

CONTACT

[email protected]

+39 02 2390 2810

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

    Time frame: 24 months

    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.

Secondary outcomes

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

    Time frame: 24 months

    The frequency of cases in which the proteogenomic subtype found in primary tumor is unchanged in distant metastases (i.e., percentage of patients with ACC-I in both primary tumor and distant metastases; percentage of patients with ACC-II in both primary tumor and distant metastases) vs. the frequency of cases in which the proteogenomic subtype found in primary tumor is different from the one found in distant metastases (i.e., percentage of patients with ACC-I in primary tumor and ACC-II in distant metastases; percentage of patients with ACC-II in primary tumor and ACC-I in distant metastases)

  2. 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)

    Time frame: 24 months

    The distribution of proteogenomic subtype found in primary tumor and the one found in patients with lung metastases vs. the frequency of proteogenomic subtype found in primary tumor and the one found in patients without lung disease (i.e., percentage of patients with lung metastasis having an ACC-I or an ACC-II profile in primary tumor; percentage of patients without lung metastasis having an ACC-I or an ACC-II profile in primary tumor)

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

    Time frame: 24 months

    The objective response rate (ORR) to systemic therapies based on the proteogenomic subtypes (i.e., ORR in patients with ACC-I vs. ORR in patients with ACC-II).

Other outcomes

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

    Time frame: 24 months

    To describe the detection rate (i.e., cases with detectable biomarker vs. undetectable biomarker) of circulating epigenomic biomarkers (e.g., ct-miRNA; ctDNA-based DNA methylation) in metastatic ACC patients

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

    Time frame: 24 months

    To describe the association with any circulating biomarker with the proteogenomic subtype (ACC-I vs. ACC-II) of pathologic specimens

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

    Time frame: 24 months

    To describe the association with any circulating biomarker with the proteogenomic subtype (ACC-I vs. ACC-II) of pathologic specimen of primary tumor

  4. To assess if the biological profile of distant metastasis can be translated on circulating blood

    Time frame: 24 months

    To describe the association with any circulating biomarker with the proteogenomic subtype (ACC-I vs. ACC-II) of pathologic specimen of distant metastases

  5. To assess if the several clinical profiles under study have an association with specific circulating biomarkers

    Time frame: 24 months

    To describe the association with any circulating biomarker with the clinical nomogram-based class (high- vs. low-risk)

  6. To assess if qualitative and/or quantitative changes of circulating biomarkers are predictive of clinical progression in ACC natural history

    Time frame: 24 months

    To describe the qualitative and/or quantitative changes of circulating biomarkers in metastatic ACC undergoing a watchful waiting approach

  7. To assess if the biological profile of the circulating biomarker is able to improve the prognostic capability of the clinical nomogram.

    Time frame: 24 months

    To describe AUC (Area Under the Curve) of overall survival prediction of the circulating biomarker alone vs. clinical nomogram alone vs. the combination of circulating biomarker and clinical nomogram.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Licitra

CONTACT

[email protected]

+39 02 2390 2810

Stefano Cavalieri

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Collaborators

  • Azienda Ospedaliera Brotzu
  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
  • Istituto Oncologico Veneto IRCCS
  • Malpighi Hospital, Bologna, Italy

Registry information

Official study title

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

Acronym: MAPPING-ACC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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