An observational study in Adenoid Cystic Carcinoma of the Salivary Gland and Adenoid Cystic Carcinoma of the Head and Neck, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational
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:
Participants will:
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.
86 studies on the registry are indexed under Carcinoma, Adenoid Cystic; 26 are open to participants now.
Browse Carcinoma, Adenoid Cystic studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
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Metastatic adenoid cystic carcinoma of head and neck
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 24 months
To assess if the proteogenomic subtype described in primary tumors is found in distant metastases
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)
Time frame: 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)
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)
Time frame: 24 months
To assess if the proteogenomic subtype found in primary tumor is associated to objective response to systemic therapy.
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).
Time frame: 24 months
To assess if circulating epigenomic biomarkers (e.g., ct-miRNA; ctDNA-based DNA methylation) are detectable in metastatic ACC patients
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
Time frame: 24 months
To assess if the biological profile of tumor specimens can be translated on circulating blood
To describe the association with any circulating biomarker with the proteogenomic subtype (ACC-I vs. ACC-II) of pathologic specimens
Time frame: 24 months
To assess if the biological profile of primary tumor can be translated on circulating blood
To describe the association with any circulating biomarker with the proteogenomic subtype (ACC-I vs. ACC-II) of pathologic specimen of primary tumor
Time frame: 24 months
To assess if the biological profile of distant metastasis can be translated on circulating blood
To describe the association with any circulating biomarker with the proteogenomic subtype (ACC-I vs. ACC-II) of pathologic specimen of distant metastases
Time frame: 24 months
To assess if the several clinical profiles under study have an association with specific circulating biomarkers
To describe the association with any circulating biomarker with the clinical nomogram-based class (high- vs. low-risk)
Time frame: 24 months
To assess if qualitative and/or quantitative changes of circulating biomarkers are predictive of clinical progression in ACC natural history
To describe the qualitative and/or quantitative changes of circulating biomarkers in metastatic ACC undergoing a watchful waiting approach
Time frame: 24 months
To assess if the biological profile of the circulating biomarker is able to improve the prognostic capability of the clinical nomogram.
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.
Time frame: 24 months
Plan to share: Undecided
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