Adenoid Cystic Carcinoma of the Salivary GlandMAPPING-ACCNCT07507578
A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma
An observational study of Adenoid Cystic Carcinoma of the Salivary Gland and Adenoid Cystic Carcinoma of the Head and Neck, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma of the Salivary Gland, Adenoid Cystic Carcinoma of the Head and Neck
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic adenoid cystic carcinoma of head and neck
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefano Cavalieri contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Lisa Licitra, +39 02 2390 2810, lisa.licitra@istitutotumori.mi.it
About this study
Official title: A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma (MAPPING-ACC)
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?
Read more
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
- Being tested
- Standard of Care (Investigator Choice)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Mar 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic Carcinoma of the Salivary GlandStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Brotzu, Istituto Oncologico Veneto IRCCS, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Azienda Ospedaliero Universitaria Maggiore della Carita, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, Malpighi Hospital, Bologna, Italy
- Responsible party
- Sponsor
- Investigators
- Lisa Licitra, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507578
- Sponsor's protocol ID
- INT156-24
- Acronym
- MAPPING-ACC
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma (MAPPING-ACC)
- ClinicalTrials.gov ID
- NCT07507578
- Acronym / sponsor ID
- MAPPING-ACC / INT156-24
- Conditions
- Adenoid Cystic Carcinoma of the Salivary Gland, Adenoid Cystic Carcinoma of the Head and Neck
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Brotzu, Istituto Oncologico Veneto IRCCS, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Azienda Ospedaliero Universitaria Maggiore della Carita, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, Malpighi Hospital, Bologna, Italy
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic adenoid cystic carcinoma of head and neck
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Other | – |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Adenoid Cystic Carcinoma of the Salivary Gland
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 2
9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
Salivary Gland Cancer, Recurrent Salivary Gland Cancer
RecruitingPhase 2
A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers
Salivary Gland Cancer, Advanced Salivary Gland Carcinoma
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Cavalieri contact
Lisa Licitra principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoid Cystic Carcinoma of the Salivary Gland and Adenoid Cystic Carcinoma of the Head and Neck, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Licitra (+39 02 2390 2810, lisa.licitra@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.