CarcinomaNCT05593744
Thyroid Dysfunction Induced by Anti-PD-1 Therapy in Patients With Advanced Carcinoma
An observational study of Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2020to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced carcinoma who received anti-PD-1 therapy at East Branch of Qilu Hospital of Shandong University
Who may be able to join
- Eighteen years or older
- Confirmed diagnosis of malignancy
- Received anti-PD-1 therapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Carcinoma
- Being tested
- no intervention
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is an observational study so not involved intervention
| Study group | Role | What they receive |
|---|---|---|
| Thyroid dysfunction | Patients had thyroid dysfunction during anti-PD-1 therapy. Receives: Other: no intervention | |
| No thyroid dysfunction | Patients didn't have thyroid dysfunction during anti-PD-1 therapy. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time between initiation of anti-PD-1 therapy and disease progression or death, whichever came first.
Measured: Through study completion, an average of 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start17 Aug 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593744
- Sponsor's protocol ID
- SDU-KYLL-202208-042
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37715029
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Thyroid Dysfunction Induced by Anti PD-1 Therapy and Prognosis in Patients With Advanced Carcinoma
- ClinicalTrials.gov ID
- NCT05593744
- Acronym / sponsor ID
- SDU-KYLL-202208-042
- Conditions
- Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid dysfunction | – | Other: no interventionPatients had thyroid dysfunction during anti-PD-1 therapy. |
| No thyroid dysfunction | – | Other: no interventionPatients didn't have thyroid dysfunction during anti-PD-1 therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced carcinoma who received anti-PD-1 therapy at East Branch of Qilu Hospital of Shandong University
Key inclusion criteria (3 listed)
- Eighteen years or older
- Confirmed diagnosis of malignancy
- Received anti-PD-1 therapy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis is an observational study so not involved intervention | Other | No thyroid dysfunction, Thyroid dysfunction |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 37715029Lu 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.
- Individual participant dataSharing planned: No
Related trials for Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Through study completion, an average of 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.