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
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
-
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Shandong
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Jinan, Shandong, China, 250014
- Qilu Hospital, Shandong University
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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.
|
This is an observational study so not involved intervention
|
|
No thyroid dysfunction
Patients didn't have thyroid dysfunction during anti-PD-1 therapy.
|
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.
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.