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

Completed

• Conditions: Carcinoma
• Interventions: Other: no intervention

• Registration Number: NCT05593744
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-17
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-23
• Last Update Submitted: 2022-10-23
• Study First Posted: 2022-10-25
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No thyroid dysfunction	no intervention	Patients didn't have thyroid dysfunction during anti-PD-1 therapy.
Thyroid dysfunction	no intervention	Patients had thyroid dysfunction during anti-PD-1 therapy.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Through study completion, an average of 17 weeks	The time between initiation of anti-PD-1 therapy and disease progression or death, whichever came first.

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China