Adenoid Cystic CarcinomaNCT04706845
Understanding the Burden of ACC Through the Eyes of Patients
An observational study of Adenoid Cystic Carcinoma, run by Ayala Pharmaceuticals, Inc, at 1 site in United States.
Trial summary
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor. Primary Objectives: To identify the specific burdens faced by patients with ACC To compare/contrast the burdens faced by patients with ACC at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 16 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Within the United States or Israel, patients who have been diagnosed with Adenoid Cystic Carcinoma (ACC)
Who may be able to join
- Participant must be a person diagnosed with ACC who is 18 years or older
- For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor
- Histologically-confirmed diagnosis of ACC with written proof of disease and molecular profile of tumor provided. This can be a note showing genetic diagnosis from a relevant testing laboratory, physician consult notes, a medical record of diagnosis, or any other single piece of documentation that connects your name/the patient's name with ACC.
- Able to read, write and understand English, Hebrew, Arabic, or Russian
- Able to grant informed consent
- Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary)
Who cannot join
- 1. Inability to meet any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.
Primary Objectives:
- To identify the specific burdens faced by patients with ACC
- To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)
Read the detailed description
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.
Primary Objectives:
- To identify the specific burdens faced by patients with ACC
- To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)
Secondary Objectives:
- To assess QoL implication in patients living with ACC (Adenoid Cystic Carcinoma)
- To compare the burdens and QoL impacts in people living with ACC, with their tumors bearing Notch mutations or Notch Wild Type due to:
- Rate of disease progression
- Location of Metastases
- Conditions
- Adenoid Cystic Carcinoma
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No evident disease | |
| 2 | Metastatic Disease; Watchful Waiting: Tumors bearing NOTCH Mutation | |
| 3 | Metastatic Disease; Watchful Waiting: Tumors bearing Notch Wild Type | |
| 4 | Progressive Disease: Tumors bearing NOTCH Mutation | |
| 5 | Progressive Disease: Tumors bearing Notch Wild Type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key burdens related to the disease or treatments
Measured: Q4-2021
Life impacts of those burdens for patient/family
Measured: Q4-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start11 Jan 2021
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayala Pharmaceuticals, Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adenoid Cystic Carcinoma Research Foundation, Memorial Sloan Kettering Cancer Center, Hadassah Medical Organization, Engage Health Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706845
- Sponsor's protocol ID
- AL Patient Burden 01
- Status last verified
- Sep 2023
- First submitted
- 11 Jan 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Burden of ACC Through the Eyes of Patients
- ClinicalTrials.gov ID
- NCT04706845
- Acronym / sponsor ID
- AL Patient Burden 01
- Conditions
- Adenoid Cystic Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ayala Pharmaceuticals, Inc,Industry (pharma, biotech, devices)
- Collaborators
- Adenoid Cystic Carcinoma Research Foundation, Memorial Sloan Kettering Cancer Center, Hadassah Medical Organization, Engage Health Inc.
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 13 Jan 2021 (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.
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.
Primary Objectives:
- To identify the specific burdens faced by patients with ACC
- To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)
Detailed description
This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.
Primary Objectives:
- To identify the specific burdens faced by patients with ACC
- To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)
Secondary Objectives:
- To assess QoL implication in patients living with ACC (Adenoid Cystic Carcinoma)
- To compare the burdens and QoL impacts in people living with ACC, with their tumors bearing Notch mutations or Notch Wild Type due to:
- Rate of disease progression
- Location of Metastases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –No evident disease |
| 2 | – | –Metastatic Disease; Watchful Waiting: Tumors bearing NOTCH Mutation |
| 3 | – | –Metastatic Disease; Watchful Waiting: Tumors bearing Notch Wild Type |
| 4 | – | –Progressive Disease: Tumors bearing NOTCH Mutation |
| 5 | – | –Progressive Disease: Tumors bearing Notch Wild Type |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Within the United States or Israel, patients who have been diagnosed with Adenoid Cystic Carcinoma (ACC)
Key inclusion criteria (6 listed)
- Participant must be a person diagnosed with ACC who is 18 years or older
- For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor
- Histologically-confirmed diagnosis of ACC with written proof of disease and molecular profile of tumor provided. This can be a note showing genetic diagnosis from a relevant testing laboratory, physician consult notes, a medical record of diagnosis, or any other single piece of documentation that connects your name/the patient's name with ACC.
- Able to read, write and understand English, Hebrew, Arabic, or Russian
- Able to grant informed consent
Key exclusion criteria (1 listed)
- 1. Inability to meet any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Key burdens related to the disease or treatments
Time frame: Q4-2021
Life impacts of those burdens for patient/family
Time frame: Q4-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Ayala Pharmaceuticals, Inc, at 1 site in United States.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key burdens related to the disease or treatments (time frame: Q4-2021). The study lists 2 primary outcomes in all. 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 29 Sep 2023.