Pituitary TumorsNCT05634655
Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary Tumors.
An observational study of Pituitary Tumors, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Tumors
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with PAs who underwent TSS at The Second Affiliated 62 Hospital Zhejiang University School of Medicine was retrospectively analyzed.
Who may be able to join
- 1) histologically confirmed PAs, 2) Non-function pituitary adenomas
Who cannot join
- 1) Associated with other tumors or serious underlying diseases, 2) the medical records were not complete, or the follow-up data were missing.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine
Hanzhou, Zhejiang
wu qun, 13605810393, 2192010@zju.edu.cn
About this study
Official title: Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary
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.
- Conditions
- Pituitary Tumors
- Being tested
- no interventions between two groups
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventions between two groupsOther
no interventions between two groups
| Study group | Role | What they receive |
|---|---|---|
| invasive PAs | Not described Receives: Other: no interventions between two groups | |
| non-invasive PAs | Not described Receives: Other: no interventions between two groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual tumor size
Tumor size was evaluated by postoperative MRI
Measured: 1 week after surgery
tumor recurrence
During the follow-up, the tumor recurrence was observed closely
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634655
- Sponsor's protocol ID
- 2021-0765
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting the Mechanism of DNA Methylation on the Invasiveness of Pituitary
- ClinicalTrials.gov ID
- NCT05634655
- Acronym / sponsor ID
- 2021-0765
- Conditions
- Pituitary Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| invasive PAs | – | Other: no interventions between two groups |
| non-invasive PAs | – | Other: no interventions between two groups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with PAs who underwent TSS at The Second Affiliated 62 Hospital Zhejiang University School of Medicine was retrospectively analyzed.
Key inclusion criteria (1 listed)
- 1) histologically confirmed PAs, 2) Non-function pituitary adenomas
Key exclusion criteria (1 listed)
- 1) Associated with other tumors or serious underlying diseases, 2) the medical records were not complete, or the follow-up data were missing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventions between two groupsno interventions between two groups | Other | invasive PAs, non-invasive PAs |
Primary outcome
Residual tumor size
Time frame: 1 week after surgery
Tumor size was evaluated by postoperative MRI
tumor recurrence
Time frame: three years
During the follow-up, the tumor recurrence was observed closely
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Pituitary Tumors
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumors, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Qun (13605810393, 2192010@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual tumor size (time frame: 1 week after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.