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

October 23, 2022 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced carcinoma who received anti-PD-1 therapy at East Branch of Qilu Hospital of Shandong University

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroid dysfunction
Patients had thyroid dysfunction during anti-PD-1 therapy.
Other: no intervention
This is an observational study so not involved intervention
No thyroid dysfunction
Patients didn't have thyroid dysfunction during anti-PD-1 therapy.
Other: no intervention
This is an observational study so not involved intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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.
Through study completion, an average of 17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 23, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 23, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDU-KYLL-202208-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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