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

NCT ID: NCT05593744

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-17

Study Completion Date

2022-03-30

Brief Summary

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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

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Conditions

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Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thyroid dysfunction

Patients had thyroid dysfunction during anti-PD-1 therapy.

no intervention

Intervention Type OTHER

This is an observational study so not involved intervention

No thyroid dysfunction

Patients didn't have thyroid dysfunction during anti-PD-1 therapy.

no intervention

Intervention Type OTHER

This is an observational study so not involved intervention

Interventions

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no intervention

This is an observational study so not involved intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

References

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Lu Y, Li Q, Xu L, Zheng Y, Wang Y, Liu Y, Zhang R, Liao L, Dong J. Thyroid dysfunction induced by anti-PD-1 therapy is associated with a better progression-free survival in patients with advanced carcinoma. J Cancer Res Clin Oncol. 2023 Dec;149(18):16501-16510. doi: 10.1007/s00432-023-05364-z. Epub 2023 Sep 15.

Reference Type DERIVED
PMID: 37715029 (View on PubMed)

Other Identifiers

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SDU-KYLL-202208-042

Identifier Type: -

Identifier Source: org_study_id

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