NCT05593744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

October 18, 2022

Last Update Submit

October 23, 2022

Conditions

Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    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

Study Arms (2)

Thyroid dysfunction

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

Other: no intervention

No thyroid dysfunction

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

Other: no intervention

Interventions

no interventionOTHER

This is an observational study so not involved intervention

No thyroid dysfunctionThyroid dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Eighteen years or older
  • Confirmed diagnosis of malignancy
  • Received anti-PD-1 therapy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250014, China

Location

Related Publications (1)

  • 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.

    PMID: 37715029DERIVED

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 25, 2022

Study Start

August 17, 2020

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)