NCT06778915

Brief Summary

To investigate the relationship between surgical margins and outcomes across different tumor stages, in order to provide evidence and guidance for refining stage-specific surgical approaches.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

7 years

First QC Date

January 9, 2025

Last Update Submit

January 14, 2025

Conditions

Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Local control

    defined as the absence of tumor persistence, recurrence, or progression at the primary tumor site following the completion of treatment, assessed by clinical examination and imaging at designated follow-up intervals.

    5 year

Secondary Outcomes (3)

  • Locoregional Recurrence-Free Survival (LRRFS)

    5 year

  • Overall Survival (OS)

    5 year

  • Distant Metastasis-Free Survival (DMFS)

    5 year

Interventions

surgeryPROCEDURE

surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

head and neck adenoid cystic carcinoma

You may qualify if:

  • patients who underwent surgical resection with curative intent and PORT.

You may not qualify if:

  • underwent only biopsy, presented with distant metastases or second primary malignancies at initial diagnosis, had incomplete clinical or histopathologic data, or had histologic evidence of high-grade transformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 16, 2025

Study Start

January 1, 2016

Primary Completion

December 31, 2022

Study Completion

August 30, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share