Understanding the Burden of ACC Through the Eyes of Patients

September 28, 2023 updated by: Ayala Pharmaceuticals, Inc,

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)

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Engage Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Within the United States or Israel, patients who have been diagnosed with Adenoid Cystic Carcinoma (ACC)

Description

Inclusion Criteria:

  1. Participant must be a person diagnosed with ACC who is 18 years or older
  2. For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor
  3. 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.
  4. Able to read, write and understand English, Hebrew, Arabic, or Russian
  5. Able to grant informed consent
  6. Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary)

Exclusion Criteria:

1. Inability to meet any of the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Key burdens related to the disease or treatments
Time Frame: Q4-2021
Q4-2021
Life impacts of those burdens for patient/family
Time Frame: Q4-2021
Q4-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayala Pharmaceuticals, Inc,

Collaborators

Memorial Sloan Kettering Cancer Center
Hadassah Medical Organization
Adenoid Cystic Carcinoma Research Foundation
Engage Health Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Actual)

August 16, 2023

Study Completion (Actual)

August 16, 2023

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL Patient Burden 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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