Radiomic and Pathomic Study of Pituitary Adenoma Using Machine Learning

Sponsor
Huashan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05108064
Collaborator
(none)
1,000
1
48
20.8

Study Details

Study Description

Brief Summary

Refractory pituitary adenoma is characterized by invasive tumor growth, continuous growth and/or hormone hypersecretion in spite of standardized multi-modal treatment such as surgeries, medications or radiations. Quality of life or even lives are threatened by these tumors. According to the 2017 World Health Organization's new classification guideline of pituitary adenoma, patients have to suffer from symptoms or complications caused by these tumors, to bear a heavy financial burden, and to accept additional therapeutic side effects when the diagnosis of "refractory pituitary adenoma" is made. If refractory pituitary adenoma could be predicted at early stage, these patients would be able to have a more frequent clinical follow-up, receive multiple effective treatment as early as possible, or even be enrolled in clinical trials of investigational medications, so as to prevent or delay the recurrence or persistent of the tumor growth. Therefore, the unmet clinical need falls into an early prediction system for refractory pituitary adenomas, which could provide accurate guidance for subsequent treatment in the early stage. The investigators have constructed a pituitary adenoma database including clinical data, radiological images, pathological images and genetic information. The investigators are proposing a study using machine learning to extract features from these multi-dimensional, multi-omics data, which could be further used to train a prediction model for the risk of refractory pituitary adenoma. The proposed model would also be validated in another prospectively collected database. The established model would be able to identify potential medication targets and provide guidance for personalized therapy of refractory pituitary adenoma.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Artificial intelligence model

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Machine Learning Modeling the Risk of Refractory Pituitary Adenoma Using Radiomic and Pathomic Data
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. The risk of refractory pituitary adenoma [10 years]

    Predicting the development of refractory pituitary adenoma after the first surgery

Secondary Outcome Measures

  1. Predicting Gamma Knife efficacy [5 years]

    Predicting endocrine remission after Gamma Knife surgery in Growth Hormone secreting pituitary adenoma

  2. Predicting immunostaining [Two weeks after surgery]

    Predicting immunostaining in patients with non-functioning pituitary adenoma using H&E stained images

  3. Predicting recurrence [10 years]

    Predicting relapse or regrowth of a non-functioning pituitary adenoma after the first surgery

  4. Predicting endocrinopathy [10 years]

    Predicting endocrinopathy which warrant replacement after pituitary adenoma resection

  5. Predicting surgical difficulty and complications [Two weeks after surgery]

    Predicting surgical difficulty and complications using pre-surgical radiomic features

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients with pituitary adenoma
Exclusion Criteria:
  • Patients who were not able to sign the informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital Shanghai Shanghai China 200040

Sponsors and Collaborators

  • Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhaoyun Zhang, Clinical Professor, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT05108064
Other Study ID Numbers:
  • KY2021-005
First Posted:
Nov 4, 2021
Last Update Posted:
Nov 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2021