NCT05634655

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 2, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

November 23, 2022

Last Update Submit

December 1, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

invasive PAs

Other: no interventions between two groups

non-invasive PAs

Other: no interventions between two groups

Interventions

no interventions between two groups

invasive PAsnon-invasive PAs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \) histologically confirmed PAs, 2) Non-function pituitary adenomas

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2ndAffiliated Hospital, School of Medicine

Hanzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissues of pititary adenomas

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 2, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 1, 2025

Last Updated

December 2, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations