NCT06484127

Brief Summary

The aim of this study was to reveal the predictive value of spatial heterogeneity and maturity difference of tertiary lymphoid structure in pathological sections of prostate cancer patients for clinical features and prognosis. It provides a new idea for the selection of prostate cancer immunotherapy population in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation between the detection of TLS(tertiary lymphoid structure) and clinical features

    1 month

Study Arms (2)

tertiary lymphoid structure positive patients

tertiary lymphoid structure negative patients

Eligibility Criteria

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

patients diagnosed with prostate cancer who underwent radical prostatectomy or prostate puncture

You may qualify if:

  • patients diagnosed with prostate cancer who underwent radical prostatectomy or prostate puncture

You may not qualify if:

  • \. incomplete medical records, inadequate follow-up information, and confirmed non-prostatic acinar adenocarcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

December 1, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations

CN(1)