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Completed

NCT Number: NCT05593744

Thyroid Dysfunction Induced by Anti-PD-1 Therapy 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.

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Key information

Conditions

Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital, Shandong University

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study so not involved intervention

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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