NCT06091878

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

October 13, 2023

Last Update Submit

August 7, 2024

Conditions

Salivary Gland Cancer

Outcome Measures

Primary Outcomes (1)

  • • 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

Study Arms (1)

Cohort 1

Other: Observation

Interventions

ObservationOTHER

Observational study, no intervention

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with a salivary gland cancer diagnosis

You may qualify if:

  • 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.

You may not qualify if:

  • Different H\&N cancer of other histology
  • Thyroid cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Pablo Jimenez

CONTACT

02073528171pablo.jimenez@rmh.nhs.uk

Sarah Burton

CONTACT

02073528171sarah.burton@rmh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

September 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2026

Last Updated

August 9, 2024

Record last verified: 2024-08