Gene Expression Profiling in a Validation Cohort of Local... | NCT06091878

Studies
Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers

NCT06091878

Sponsor

Royal Marsden NHS Foundation Trust

Status

Not yet recruiting

Last Update Posted

Aug 9, 2024Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Salivary Gland Cancer

Interventions

Observation

Countries

Not provided

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Estimated

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 13, 2023

First Posted Date

Oct 19, 2023Actual

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

Aug 7, 2024

Last Update Posted Date

Aug 9, 2024Actual

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

The INDAGA-UK trial is a retrospective, multi-centre observational study in participants with locally advanced and recurrent salivary gland to investigate t its molecular profiling, and to explore new prognostic and druggable markers. We will analyse samples and data from patients diagnosed with salivary gland cancer from 2013 - 2023. Subject and sample identification will occur over a 12-month period. Samples and data will be analysed over the next 12 months prior to study end.

Detailed Description

Not provided

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

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1			Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Observational study, no intervention	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs.	• Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs.	Time Frame: Through study completion, expected duration of 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged over 18
Histological diagnosis of salivary gland cancer (SGCs)
Availability of archival tissue (acceptable after 2013 up to present)
Ability to give informed consent (if applicable)* for retrieving histological specimen and preform molecular analysis *De-identified archival tissue from deceased patients will be collected as part of the study once REC approval is in place, if the patient was alive when the samples were taken and they are not part of the NHS opt out scheme.

Exclusion Criteria:

Different H&N cancer of other histology
Thyroid cancers

Accepts Healthy Volunteers

Not provided

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

Participants with a salivary gland cancer diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pablo Jimenez	Contact	02073528171		pablo.jimenez@rmh.nhs.uk
Sarah Burton	Contact	02073528171		sarah.burton@rmh.nhs.uk

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012468	Salivary Gland Neoplasms

Ancestor Terms

ID	Term
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided