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NCT05593744 Clinical Trial

Thyroid Dysfunction Induced by Anti-PD-1 Therapy in Patients With Advanced Carcinoma

Carcinoma Clinical Trial

Official title:
Study on the Correlation Between Thyroid Dysfunction Induced by Anti PD-1 Therapy and Prognosis in Patients With Advanced Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05593744
Other study ID # SDU-KYLL-202208-042
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2020
Est. completion date March 30, 2022

Study information
Verified date October 2022
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, we monitored patients with advanced malignant tumors who received anti-PD-1 therapy to observe the characteristic of anti-PD-1 therapy-induced thyroid dysfunction and its correlation with prognosis.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eighteen years or older - Confirmed diagnosis of malignancy - Received anti-PD-1 therapy Exclusion Criteria: - Thyroid malignancy or history of thyroid malignancy - Thyroid dysfunction before anti-PD-1 therapies - Previous ICIs treatment - Less than 2 cycles of anti-PD-1 treatment - No thyroid function monitoring during treatment - Known pituitary disease - Pregnancy.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
This is an observational study so not involved intervention

Locations
Country Name City State
China Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival The time between initiation of anti-PD-1 therapy and disease progression or death, whichever came first. Through study completion, an average of 17 weeks
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