Understanding the Burden of ACC Through the Eyes of Patients | NCT04706845

Studies
Understanding the Burden of ACC Through the Eyes of Patients

NCT04706845

Sponsor

Ayala Pharmaceuticals, Inc,

Status

Completed

Last Update Posted

Sep 29, 2023Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Adenoid Cystic Carcinoma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2021Actual

Primary Completion Date

Aug 16, 2023Actual

Completion Date

Aug 16, 2023Actual

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Jan 11, 2021

First Posted Date

Jan 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2023

Last Update Posted Date

Sep 29, 2023Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

1. Inability to meet any of the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Engage Health		Eagan	Minnesota	55121	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003528	Carcinoma, Adenoid Cystic

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

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