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

Official title

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

Overview

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.

Interventions

• Other Standard of Care (Investigator Choice)
  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

Primary outcome measures

• 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]

Secondary outcome measures (3)

• To assess if the proteogenomic subtype described in primary tumors is found 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) [Time frame: 24 months]
• To assess if the proteogenomic subtype found in primary tumor is associated to objective response to systemic therapy. [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan

Identifiers

NCT: NCT07507578 · INT156-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗