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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05634655
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 13.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Tumors	Other: no interventions between two groups

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
invasive PAs	Other: no interventions between two groups; no interventions between two groups
non-invasive PAs	Other: no interventions between two groups; no interventions between two groups

Outcome Measures

Primary Outcome Measures

1. Residual tumor size [1 week after surgery]

   Tumor size was evaluated by postoperative MRI

2. tumor recurrence [three years]

   During the follow-up, the tumor recurrence was observed closely

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2ndAffiliated Hospital, School of Medicine	Hanzhou	Zhejiang	China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05634655
• Other Study ID Numbers: 2021-0765
• First Posted: Dec 2, 2022
• Last Update Posted: Dec 2, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pituitary Neoplasms; Pituitary Diseases

Study Results

No Results Posted as of Dec 2, 2022