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| Name | Class |
|---|---|
| Azienda Ospedaliera Brotzu | OTHER |
| Istituto Oncologico Veneto IRCCS | OTHER |
| Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale | NETWORK |
| Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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Metastatic adenoid cystic carcinoma of head and neck
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Licitra | Contact | +39 02 2390 2810 | lisa.licitra@istitutotumori.mi.it | |
| Stefano Cavalieri | Contact | stefano.cavalieri@istitutotumori.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Licitra | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
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| UNKNOWN |
| IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | OTHER |
| Malpighi Hospital, Bologna, Italy | OTHER |
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The study will keep:
From these samples, researchers may analyze:
No additional procedures beyond routine tumor collection and two small blood draws are required to obtain these samples.
| 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) | 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). | 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 | 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 | 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 | 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) | 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 | 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. | 24 months |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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