NCT06130683

Brief Summary

This project intends to select cases that meet the research requirements, take secondary hyperparathyroidism, primary hyperparathyroidism and normal human parathyroid tissue, a total of three groups, 4 cases in each group, through the method of single-cell transcription and sequencing, construct a map of human parathyroid function types, reveal the gene structure and gene expression status of cells, and visualize the expression characteristics, intercellular heterogeneity, and heterogeneity of cell subsets of secondary hyperparathyroid cells in a hierarchical manner, draw a single-cell map, and compare the differences between groups. To explore the pathogenesis of secondary hyperparathyroidism. Secondary hyperparathyroidism, parathyroid tissue of primary hyperparathyroidism and normal parathyroid tissue obtained by accident were collected, frozen and preserved, frozen tissue thawed, single-cell suspension was prepared and each cell was specifically labeled by the Mozhuo Genomics system, after oil breaking, polymerase chain reaction amplification, reverse transcription to obtain complementary DNA, and a library of complementary DNA that passed quality inspection was constructed to obtain high-quality data of parathyroid cells. Cell Ranger, R Seurat package, and t-SNE dimensionality reduction diagram were used to reduce the dimensionality, cluster, and visualize the data. In order to construct a single-cell atlas of parathyroid glands, investigators performed cluster analysis of similar cells according to the gene expression profile, and then visualized the data by t-SNE. According to the results of cell clustering, the specific and highly expressed genes in each cell cluster were identified. Cell populations were identified according to the expression of landmark genes, and the differences in cell types and proportions between groups were compared.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

November 3, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

November 3, 2023

Last Update Submit

December 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Construct the single-cell atlas

    A single-cell atlas of normal parathyroid, primary hyperparathyroidism, and secondary hyperparathyroidism was constructed. Differential analysis is performed to explore differences in gene expression. Next step is to perform kegg and analyze the pathway information. Cell populations are used to explore changes in cell state during population progression. Quasi-temporal analysis is designed to delineate the dynamic trajectory of cell differentiation and the dynamic process of gene expression. SCENIC is a network for inferring gene co-expression. Investigators will use software such as CellRanger and the Seurat package in R word to implement this.

    One year

Study Arms (3)

Secondary Hyperparathyroidism

Patients who were diagnosed as secondary hyperparathyroidism

Other: Single-cell sequencing

Primary Hyperparathyroidism

Patients who were diagnosed as primary hyperparathyroidism

Other: Single-cell sequencing

Normal group

Parathyroid tissue obtained incidentally during other neck surgeries, derived from people without parathyroid disease.

Other: Single-cell sequencing

Interventions

Single-cell sequencing technology can reveal the gene structure and gene expression status of individual cells, reflecting the heterogeneity between cells.

Normal groupPrimary HyperparathyroidismSecondary Hyperparathyroidism

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who undertake surgery for secondary hyperparathyroidism or primary hyperparathyroidism and other neck surgeries in our China-Japan Friendship Hospital

You may qualify if:

  • Study participants with a diagnosis of secondary hyperparathyroidism who underwent surgical treatment
  • Study participants with a diagnosis of primary hyperparathyroidism who underwent surgical treatment
  • Study participants who have obtained informed consent

You may not qualify if:

  • Refusal of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China and Japan Friendship Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Parathyroid glands

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Meng Yang

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 14, 2023

Study Start

November 10, 2023

Primary Completion

December 8, 2024

Study Completion

July 31, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations