Dissecting the Mechanism of DNA Methylation on the Invasi... | NCT05634655

Studies
Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary Tumors.

NCT05634655

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Dec 2, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pituitary Tumors

Interventions

no interventions between two groups

Countries

China

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Nov 23, 2022

First Submission Date that Met QC Criteria

Dec 1, 2022

First Posted Date

Dec 2, 2022Actual

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

Dec 1, 2022

Last Update Posted Date

Dec 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

DNA methylation is one of the important ways of protein post-translational modification.Pituitary adenoma (PA) is a benign neuroendocrine tumor that originates from adenohypophysial 45 cells, and accounts for 10%-20% of all primary intracranial tumors. However some PAs can present with high invasiveness and irregular growth, which tend to compresses the optic chiasm and third ventricle, encase the internal carotid artery, and affect hormone secretion from the pituitary gland and hypothalamus. In this study we focus on the mechanism of DNA methylation on the invasiveness of pituitary tumors.

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

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
invasive PAs			Other: no interventions between two groups
non-invasive PAs			Other: no interventions between two groups

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no interventions between two groups	Other	no interventions between two groups	invasive PAs non-invasive PAs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Residual tumor size	Tumor size was evaluated by postoperative MRI	1 week after surgery
tumor recurrence	During the follow-up, the tumor recurrence was observed closely	three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) histologically confirmed PAs, 2) Non-function pituitary adenomas

Exclusion Criteria:

1) Associated with other tumors or serious underlying diseases, 2) the medical records were not complete, or the follow-up data were missing.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients with PAs who underwent TSS at The Second Affiliated 62 Hospital Zhejiang University School of Medicine was retrospectively analyzed.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wu Qun	Contact	13605810393		2192010@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2ndAffiliated Hospital, School of Medicine	Recruiting	Hanzhou	Zhejiang		China

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
D010911	Pituitary Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided