Surgical Strategy for Head and Neck Adenoid Cystic Cancer | NCT06778915

Studies
Surgical Strategy for Head and Neck Adenoid Cystic Cancer

NCT06778915

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Completed

Last Update Posted

Jan 16, 2025Actual

Enrollment

309Actual

Phase

Not provided

Conditions

Adenoid Cystic Carcinoma

Interventions

surgery

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

Jan 2025

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 1, 2016Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Aug 30, 2024Actual

First Submitted Date

Jan 9, 2025

First Submission Date that Met QC Criteria

Jan 14, 2025

First Posted Date

Jan 16, 2025Actual

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

Jan 14, 2025

Last Update Posted Date

Jan 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guopei Zhu, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Adenoid cystic carcinoma of the head and neck (HNACC) presents unique surgical challenges due to its propensity for perineural spread and proximity to critical craniofacial structures. While surgical resection remains the cornerstone of treatment, determining the optimal extent of resection to balance oncologic control and functional preservation requires further investigation. The investigator aimed 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.

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

309Actual

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Locoregional Recurrence-Free Survival (LRRFS)	time from treatment initiation to either locoregional recurrence or death from any cause	5 year
Overall Survival (OS)	time from treatment initiation to death from any cause

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent surgical resection with curative intent and PORT.

Exclusion Criteria:

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.

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

head and neck adenoid cystic carcinoma

Sampling Method

Probability Sample

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

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided